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U.S. Department of Health and Human Services

Class 2 Device Recall NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONS

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 Class 2 Device Recall NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONSsee related information
Date Initiated by FirmApril 26, 2010
Date PostedSeptember 13, 2010
Recall Status1 Terminated 3 on March 28, 2011
Recall NumberZ-2415-2010
Recall Event ID 55876
510(K)NumberK043101 
Product Classification prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductNexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 8, sterile, REF 00-5950-057-02, 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.
Code Information 103044, 60276808, 60282368, 60292625, 60296123, 60296124, 60307227, 60315651, 60328159, 60331388, 60331389, 60339651, 60343929, 60343930, 60343931, 60343932, 60343933, 60343934, 60343935, 60355713, 60362083, 60365658, 60384329, 60534175, 60570899, 60578778, 60584754, 60616292, 60625488, 60640829, 60692575, 60727493, 60760516, 60818767, 60867946, 60892877, 60917518, 60955232, 60983707, 61113641 and 61143803
Recalling Firm/
Manufacturer		 Zimmer Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact
574-267-6131
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Other
ActionThe 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.
Quantity in Commerce68,384 all products
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JWH
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