Original (click the link): DePuy Adept Recall UK
Product Name: ADEPT® 12/14 Modular Head (Finsbury Orthopaedics Ltd)
Type of Action: Field Safety Corrective Action
Date: 15th January 2013
Type of device: Total Hip Replacement Implant
Model names: ADEPT® 12/14 Modular Head (Finsbury Orthopaedics Ltd)
Model number: Reference Appendix A
Batch / lot number of affected devices: All lots
DePuy is issuing a field safety corrective action (FSCA) for all lots of the ADEPT® 12/14 Modular Head used in total hip arthroplasty. If you have any remaining inventory please cease further distribution or use of the product with immediate effect.
Review of post‐market surveillance data suggests a higher than expected revision rate for the ADEPT®
12/14 Modular Head (Finsbury Orthopaedics Ltd) when used in conventional Total Hip Arthroplasty.
The ADEPT® 12/14 Modular Head was manufactured by Finsbury Orthopaedics Ltd. Finsbury was acquired by DePuy in December 2009. ADEPT® 12/14 Modular Heads were available commercially from Finsbury or DePuy from 2004 to September 2011. From September 2011, ADEPT® 12/14 Modular Heads were acquired by MatOrtho Ltd.
Note: This Field Safety Notice does not apply to ADEPT® Hip Resurfacing Femoral components.
Analysis of UK National Joint Registry Supplier Feedback data (download 11th November 2012) indicates a cumulative revision rate of 12.1% (95% CI 9.5% to 15.4%) at 7 years for the ADEPT® 12/14 Modular Head when used in conventional Total Hip Arthroplasty. When this combination is used with the
ADEPT® Cementless Stem, the data showed a cumulative revision rate of 9.7% (95% CI 5.9% to 15.5%) at five years. This is based on 17 revisions in a cohort of 195 implantations.
Whilst there are differences in the relative performance of particular stem combinations with the
ADEPT® 12/14 Modular Head, and the cohort sizes for other head/stem combinations detailed below
are small, the aggregate data shows a cumulative revision rate of 9.6% (95% CI 6.7% to 13.7%) at 5 years for approved ADEPT® 12/14 Modular Head ‐ stem combinations. Data for all approved combinations is shown below.
This data suggests a higher than expected revision rate for the ADEPT ® 12/14 Modular Head (Finsbury Orthopaedics Ltd) when used in conventional Total Hip Arthroplasty. Based on the aggregate data, we are initiating a FSCA on the ADEPT ® 12/14 Modular Head (Finsbury Orthopaedics Ltd).
Adept XL Type (Head/Stem) Cumulative Revision Rate No Implanted / No
|Adept/Adept Cementless||9.65% (95% CI 5.93% to 15.51%) at 5 years||195 / 17|
|Adept/Corail||4.35% (95% CI 1.11% to 16.29%) at 2 years||46 / 5|
|Adept/Freeman CementedFinsbury||Not Available due to small cohort||
1 / 0
|Adept/Freeman Cementless||2.44% (95% CI 0.35% to 16.08%) at 3 years||46 / 3|
|Adept/Finsbury Type C||2.08% (95% CI 0.30% to 13.88%) at 2 years||48 / 3|
|Adept/LPR||6.67% (95% CI 2.20% to 19.26%) at 2 years||45 / 4|
The primary reasons for revision surgery are:
• Aseptic loosening of the stem
• Soft tissue reaction
In September 2012, the Australian Orthopaedic Association National Joint Replacement Registry reported a cumulative revision rate of 7.1% (95% CI 3.6% to 13.6%) at 3 years with 8 revisions in a cohort of 121 ADEPT® 12/14 Modular Head cases used in conventional Total Hip Arthroplasty. The on‐label cohorts remain small with no revisions due to metal sensitivity (4 loosening/lysis, 2 infection, 1 prosthesis dislocation and 1 pain).
Please undertake the following urgent actions:
- Quarantine/Bond any ADEPT® 12/14 Modular Head inventory that is located at your facility or hospital.
- Arrange with your local DePuy representative to return for credit any unused implants
- Please sign and return the confirmation/reconciliation letter below to the specified DePuy contact.
- Please ensure all departments and colleagues within your organisation who are impacted by this
- Field Safety Corrective Action notification are made aware of this action.
Patients who have received the ADEPT® 12/14 Modular Head should be followed according to local guidance/standard of care for patients receiving metal on metal (MoM) articulations. Please refer to your local orthopaedic association for detailed information related to the treatment of patients with metal‐on‐metal articulations.
Transmission of this Field Safety Notice:
This notice has been sent to you as records indicate that your organisation has purchased the ADEPT® Modular Head.
This notice needs to be passed on to all those who need to be aware within your organisation or to any organisation where these products may have been transferred.
For any enquiries regarding the ADEPT® System (Finsbury Orthopaedics Ltd):
Alan O’ Sullivan (DePuy) Recall Coordinator
e‐mail – firstname.lastname@example.org
Tel no ‐ +353 21 4914149
This FSN has been notified to the appropriate Regulatory Agency.
This Letter acknowledges receipt of the Field Safety Notice [ref. DVA‐107259‐
HHE] dated [INSERT DATE] issued by DePuy Orthopaedics.
We have checked our current inventory:
(Please check as appropriate)
No ADEPT® 12/14 Modular Head(s) are located at our facility.
Please fax or e‐mail this completed document to [INSERT DePuy Marketing Company/Affiliate contact details]
The products listed below are in our inventory and will be returned to DePuy
Orthopaedics or a representative of DePuy. (Add rows as required)
|Part Number||LOT/Batch Number||Quantity|
City, State, Post Code/Zip
Telephone Number or e‐mail address
Note: When returning inventory please ensure this letter accompanies any returns
ADEPT® 12/14 Modular Head
|Product CodeDePuy||Product CodeFinsbury||Description|
|180238F||180238||ADEPT® 12/14 MoM Mod Head 38 mm ‐3.5 mm Neck|
|180240F||180240||ADEPT® 12/14 MoM Mod Head 40 mm ‐3.5 mm Neck|
|180242F||180242||ADEPT® 12/14 MoM Mod Head 42 mm ‐3.5 mm Neck|
|180244F||180244||ADEPT® 12/14 MoM Mod Head 44 mm ‐3.5 mm Neck|
|180246F||180246||ADEPT® 12/14 MoM Mod Head 46 mm ‐3.5 mm Neck|
|180248F||180248||ADEPT® 12/14 MoM Mod Head 48 mm ‐3.5 mm Neck|
|180250F||180250||ADEPT® 12/14 MoM Mod Head 50 mm ‐3.5 mm Neck|
|180252F||180252||ADEPT® 12/14 MoM Mod Head 52 mm ‐3.5 mm Neck|
|180254F||180254||ADEPT® 12/14 MoM Mod Head 54 mm ‐3.5 mm Neck|
|180256F||180256||ADEPT® 12/14 MoM Mod Head 56 mm ‐3.5 mm Neck|
|180258F||180258||ADEPT® 12/14 MoM Mod Head 58 mm ‐3.5 mm Neck|
|180338F||180338||ADEPT® 12/14 MoM Mod Head 38 mm +0 mm Neck|
|180340F||180340||ADEPT® 12/14 MoM Mod Head 40 mm +0 mm Neck|
|180342F||180342||ADEPT® 12/14 MoM Mod Head 42 mm +0 mm Neck|
|180344F||180344||ADEPT® 12/14 MoM Mod Head 44 mm +0 mm Neck|
|180346F||180346||ADEPT® 12/14 MoM Mod Head 46 mm +0 mm Neck|
|180348F||180348||ADEPT® 12/14 MoM Mod Head 48 mm +0 mm Neck|
|180350F||180350||ADEPT® 12/14 MoM Mod Head 50 mm +0 mm Neck|
|180352F||180352||ADEPT® 12/14 MoM Mod Head 52 mm +0 mm Neck|
|180354F||180354||ADEPT® 12/14 MoM Mod Head 54 mm +0 mm Neck|
|180356F||180356||ADEPT® 12/14 MoM Mod Head 56 mm +0 mm Neck|
|180358F||180358||ADEPT® 12/14 MoM Mod Head 58 mm +0 mm Neck|
|180438F||180438||ADEPT® 12/14 MoM Mod Head 38 mm +3.5 mm Neck|
|180440F||180440||ADEPT® 12/14 MoM Mod Head 40 mm +3.5 mm Neck|
|180442F||180442||ADEPT® 12/14 MoM Mod Head 42 mm +3.5 mm Neck|
|180444F||180444||ADEPT® 12/14 MoM Mod Head 44 mm +3.5 mm Neck|
|180446F||180446||ADEPT® 12/14 MoM Mod Head 46 mm +3.5 mm Neck|
|180448F||180448||ADEPT® 12/14 MoM Mod Head 48 mm +3.5 mm Neck|
|180450F||180450||ADEPT® 12/14 MoM Mod Head 50 mm +3.5 mm Neck|
|180452F||180452||ADEPT® 12/14 MoM Mod Head 52 mm +3.5 mm Neck|
|180454F||180454||ADEPT® 12/14 MoM Mod Head 54 mm +3.5 mm Neck|
|180456F||180456||ADEPT® 12/14 MoM Mod Head 56 mm +3.5 mm Neck|
|180458F||180458||ADEPT® 12/14 MoM Mod Head 58 mm +3.5 mm Neck|
|180538F||180538||ADEPT® 12/14 MoM Mod Head 38 mm +7 mm Neck|
|180540F||180540||ADEPT® 12/14 MoM Mod Head 40 mm +7 mm Neck|
|180542F||180542||ADEPT® 12/14 MoM Mod Head 42 mm +7 mm Neck|
|180544F||180544||ADEPT® 12/14 MoM Mod Head 44 mm +7 mm Neck|
|180546F||180546||ADEPT® 12/14 MoM Mod Head 46 mm +7 mm Neck|
|180548F||180548||ADEPT® 12/14 MoM Mod Head 48 mm +7 mm Neck|
|180550F||180550||ADEPT® 12/14 MoM Mod Head 50 mm +7 mm Neck|
|180552F||180552||ADEPT® 12/14 MoM Mod Head 52 mm +7 mm Neck|
|180554F||180554||ADEPT® 12/14 MoM Mod Head 54 mm +7 mm Neck|
|180556F||180556||ADEPT® 12/14 MoM Mod Head 56 mm +7 mm Neck|
|180558F||180558||ADEPT® 12/14 Metal on Metal Modular Head 58mm+7mm Neck|
- J&J again recalls thousands of faulty hip implants – US News and World Report (earlsview.com)
- Severe Metallosis Leading to Femoral Head Perforation | Orthopedics (earlsview.com)
- Dr Tower writes to Senator re concerns about the regulatory malfeasance at the FDA – Metal-on-Metal hip replacement debacle (earlsview.com)
- “What a Mistake,” says DePuy Hip Recipient (earlsview.com)
- During Trial, New Details Emerge on DuPuy Hip – NYTimes.com (earlsview.com)
- DePuy Recall News: The Rottenstein Law Group Responds to Another Johnson & Johnson Metal-on-Metal Hip Implant Recall (prweb.com)
- DePuy ASR Hip Lawsuit Update: Bernstein Liebhard LLP Weighs in On Latest Development in DePuy ASR Recall Trial (prweb.com)
- Metal-on-metal hip replacement toxicity | NPS MedicineWise (earlsview.com)
- Johnson & Johnson recalls more metal hip implants (medcitynews.com)
- Patients victims of untested medical devices – SFGate (earlsview.com)