Acetabulum, FDA, Food & Drug Administration, Hip Replacement, New York TImes, UNited States, Zimmer, Zimmer Holdings
I would be extremely bloody unlucky if this particular batch number was used in my revision operation! If I did – I will be out to buy a lottery ticket!
I have contacted my surgeon to see what he knows…
Here is the FDA recall letter – click here
|Class 2 Recall
Zimmer Trabecular Metal Modular Acetabular System
|Date Posted||September 27, 2011|
|Product||The Trabecular Metal Modular Acetabular System is a modular acetabular cup system consisting of a shell with a preassembled locking ring, a liner, and optional screws. The Shells are available in a variety of sizes and are designed to be used with Trilogy Acetabular System liners. The shell implants are used to replace the hip socket during total hip arthroplasty. The device is indicated for primary or revision surgery for rehabilitating hips damaged as a result on noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis,protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis and diastrophic variant. The device is intended for either cemented or noncemented use.|
|Code Information||Part 00-6202-052-21, Lot 61132698|
345 E Main St
Warsaw, Indiana 46580-2746
|Consumer Instructions||Contact the recalling firm for information|
|For Additional Information Contact||Cheryl A. Trease
|Lot # 61132698, may have a manufacturing non conformance that could prevent the devices from functioning as intended. Specifically, devices in the affected lot may have a locking ring groove depth that prevents the corresponding liner from snapping into the shell. The groove provides the locking ring room to displace when inserting a liner into the shell. There has been one reported incident w|
|Action||Zimmer, Inc. sent an “URGENT MEDICAL DEVICE RECALL” letter dated July 27, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to stop using and to quarantine the affected product. An Inventory Return Certification Form was included with the letter for customers to complete and return to Zimmer, Inc. via fax at (574) 372-4265. Replacement product will be provided for all returned product. Contact Zimmer, Inc. at 1-800-613-6131 for questions regarding this recall.|
|Quantity in Commerce||23 devices|
|Distribution||Worldwide Distribution-USA (nationwide) including the states of CA, NC,NY, PA, WA, and WI and countries of Australia, Germany, The Netherlands, and Switzerland.|
FDA Recalls Zimmer Trabecular Metal Modular Acetabular System
Published on: September 30th, 2011 12:02am This Press Release (OPENPRESS) September 30, 2011 —
On September 27, 2011, US Food and Drug Administration (FDA) recalled the Trabecular Metal Modular Acetabular System manufactured by Zimmer Inc.
The Trabecular Metal Modular Acetabular System is a modular acetabular cup system consisting of a shell with a pre-assembled locking ring, a liner, and optional screws. The shell implants are used to replace the hip socket during total hip arthroplasty.
According to the FDA’s notice, devices within Lot # 61132698 may have a locking ring groove depth that prevents the corresponding liner from snapping into the shell, thereby prompting this recall.
In late July, letters were to be sent to all affected customers with instructions on how to proceed.
This recall comes amidst a time wherein recent data indicates that metal-on-metal (MoM) hip implants have suffered a high adverse event rate in general.
According to The New York Times, the FDA received more than 5,000 adverse event reports in the first six months of 2011 regarding MoM hips, which was more than the agency had received in the prior four years combined.
To conduct its analysis, The New York Times reviewed complaints filed with the FDA for the past four years for several implants, including the Acetabular Replacement System (ASR) manufactured by DePuy Orthopaedics, Inc., a Johnson & Johnson Company, as well as the Durom Acetabular Component (Durom Cup), yet another device manufactured by Zimmer Inc.
Interestingly, the Durom Cup was recalled in July 2008.
Ennis & Ennis, P.A. recommends that anyone with a Trabecular Metal Modular Acetabular System from the recalled Lot #, first seek medical attention.
Then file an adverse event report with the FDA at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm.
Lastly, consult with an experienced attorney to explore your legal rights.
Ennis & Ennis is offering free, nationwide, confidential consultations to anyone who has a MoM hip replacement system by calling toll free 1-800-856-6405 or by going to http://www.ennislaw.com and completing an online case evaluation form. Ennis & Ennis, P.A. is a nationwide law firm with offices in Ft. Lauderdale, Miami and Washington D.C.
Ennis & Ennis, P.A. concentrates it practice in mass torts and represents individuals against pharmaceutical companies worldwide, as well as medical device makers. Ennis & Ennis, P.A. has been representing clients individually since 1986 and has recovered over $100 million in settlements for its clients. Ennis & Ennis, P.A. is also investigating cases involving, Accutane, Actos, Avandia, Fosamax, Paxil, Zoloft, Prozac, Depuy Hip Recall, Zimmer Hip Recall, Depakote, Reglan, SJS/Dilantin, Yaz, Yasmin and Ocella Birth Control Pills and transvaginal mesh devices. Remember the law limits the time in which you can file a claim, so don’t wait to explore your legal rights. Call today toll free 1-800-856-6405 or visit http://www.ennislaw.com. ###
Ennis & Ennis, P.A. Phone: 1-800-856-6405 E-mail: Click Here to Send Web site: http://www.ennislaw.com Ennis & Ennis, P.A. 1101 Pennsylvania Avenue Washington, DC 20004 Release Information Industry: Legal / Law, More Press Releases from Legal / Law Country: United States, More Press Releases from United States MSA (Metropolitan Statistical Area): Washington, DC-MD-VA-WV, More Press Releases from Washington, DC-MD-VA-WV Company: Ennis & Ennis, P.A. Web site: Visit our web site
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