—#92118

Product

NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 2, sterile, REF 00-5950-027-02, Zimmer Inc. Warsaw, IN. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K043101
Affected lot / code info: 111131, 7881879, 60263536, 60282367, 60292618, 60292620, 60292623, 60296117, 60296118, 60296119, 60302285, 60312260, 60315642, 60317607, 60321945, 60328158, 60328161, 60331376, 60334521, 60362084, 60372785, 60372786, 60380755, 60457190, 60457195, 60460069, 60472448, 60476747, 60480951, 60492608, 60497690, 60502850, 60512205, 60518609, 60523102, 60538366, 60542934, 60554995, 60562933, 60566980, 60575470, 60578770, 60582736, 60593836, 60595803, 60608104, 60612399, 60616286, 60621119, 60625489, 60631132, 60634788, 60640822, 60649151, 60660341, 60667948, 60677455, 60682185, 60686882, 60692576, 60701924, 60711156, 60717978, 60732156, 60732158, 60748243, 60752980, 60760509, 60765124, 60775800, 60782863, 60785781, 60790429, 60801746, 60809057, 60816237, 60818763, 60823402, 60840790, 60847122, 60854122, 60867943, 60873473, 60881693, 60895096, 60895105, 60909839, 60917515, 60929865, 60929872, 60934274, 60942490, 60949438, 60949442, 60959681, 60967997, 60969509, 60979127, 60983699, 60987129, 60994895, 61006364, 61006366, 61022793, 61022794, 61029263, 61034993, 61045015, 61050232, 61057516, 61064204, 61090790, 61097029, 61100563, 61113637, 61116565, 61121501, 61128962, 61133865, 61138441, 61138448, 61149375, 61154238, 61158295, 61174187, 61181644, 61181648, 61193863, 61198699, 61211009, 61216067, 61225956, 61231012, 61245335, 61248779, 61253733, 61259044, 61259045, 61259059, 61262894, 61262895, 61262903, 61262904, 61262905, 61267824, 61267825, 61267843, 61272582, 61272598, 61277589, 61280559, 61280560, 61285875, 61285890, 61285892, 61289981, 61289994, 61295484, 61295485, 61298635, 61302107, 61302116, 61307076, 61307086, 61311098, 61315686, 61315687, 61319839, 61319850, 61324494, 61324506, 61324507, 61329234, 61334540, 61338267, 61338286, 61344102, 61344103, 61350284, 61350285, 61350286, 61355734, 61355735, 61355736, 61355743, 61355744, 61355745, 61360859, 61360860, 61365234, 61365248, 61370239, 61370249, 61370250, 61376578, 61376588, 61376589, 61380424, 61380425, 61380436, 61380437, 61380438, 61386637, 61386638, 61390830, 61390831, 61395038, 61395039, 61395040, 61399697, 61399698 and 61399699.

Why it was recalled

The firm has received complaints of loosening of the implanted device requiring revision surgery. There have been 114 MDRs filed all reported that the device loosened and the patient required additional surgery to replace the device.

Root cause (FDA determination)

Other

Action the firm took

The firm, Zimmer, Inc., sent an "URGENT DEVICE CORRECTION" letter dated April 26, 2010, to all customers. The letter described the product, problem and action to be taken by customers. The customers were instructed to destroy or disregard all previous versions of the surgical technique, review the attached revised surgical technique to familiarize yourself with the modifications and warnings, and complete and return the Health Care Professional Dcoumentation Form via fax to Zimmer, Inc. at (574) 372-4265. (Note: Zimmer made a modification to the surgical technique and instructions for use. They added a warning to fully cement and pressurize the anterior and posterior surfaces of the tibial component, and to strongly recommend the use of a drop down stem extension. This change was completed and approved on April 23, 2010.) For questions please contact Zimmer at 1-877-946-2761.

Recalling firm

Firm: Zimmer Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: Worldwide distribution: USA including states of AZ, IL, IN, KY, MO, NE, NM, NY, OH, TX, VA, WA, and WI; and countries of Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, UK, Ausralia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, Tawain and Thailand.

Timeline

Recall initiated: 2010-04-26
Posted by FDA: 2010-09-13
Terminated: 2011-03-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #92118. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.