DePuy Adept Recall UK

Original (click the link): DePuy Adept Recall UK

Product Name: ADEPT® 12/14 Modular Head (Finsbury Orthopaedics Ltd)

FSCA‐identifier: DVA‐107259‐HHE

Type of Action: Field Safety Corrective Action

Date: 15th January 2013

Attention: Trust Chief Executives, the Clinical Director‐Orthopaedic Department, the Orthopaedic Theatre Manager, the Safety Liaison Officer, General Managers – Private Sector Hospitals

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

Action:

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.

Summary:

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.

Background:

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

Revised

The primary reasons for revision surgery are:

•    Aseptic loosening of the stem

•    Soft tissue reaction

•    Pain

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.

Patient Care:

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):

Contact

Alan O’ Sullivan (DePuy) Recall Coordinator

e‐mail – aosulliv@its.jnj.com

Tel no ‐ +353 21 4914149

This FSN has been notified to the appropriate Regulatory Agency.

Date: 15‐Jan‐2013

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.

or

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)

Print Name:                                                                                                                        

Signature

Hospital Name

Country

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

Appendix A