—#114651

Product

Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE F, LEFT TIBIA SIZE F RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K113369
Affected lot / code info: Part Number 42-5320-075-01 TIBIA SIZE F, LEFT, Lot: 11006654, 11007213, 11007237, 62018347, 62018348, 62033393, 62040514, 62060745, 62068420, 62076584, 62079762, 62079763, 62079764, 62091367, 62110202, 62110203, 62117661, 62144988, Part Number 42-5320-075-02 TIBIA SIZE F RIGHT, Lot: 11006575, 11006983, 11007033, 62018349, 62018350, 62033395, 62040515, 62065655, 62067342, 62076587, 62079765, 62079766, 62091368, 62110204, 62117662, 62103728, 11007768, 62140221, 62144989,

Why it was recalled

All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

Root cause (FDA determination)

Device Design

Action the firm took

Zimmer sent distributors beginning the week of November 14, 2012, E-mail information requesting all equipment be collected in distributors office before shipment back to Zimmer and replacement. A telephone conference discussing the recall and amended surgical technique was held the week of November 14, 2012, and Urgent Recall notices were sent to Distributors describing the devices; risks; updated surgical technique with directions to hand deliver surgeon/risk manager letters to all affected surgeons and risk managers in hospitals receiving the product. The notices included directions to remove all affected product and ensure risk manager letter is provided. The letter stated a Zimmer Inc. employee will conduct onsite reconciliation and asked return of distribution Spreadsheet to CorporateQuality.Postmarket@zimmer.com within 24 hours of receiving notification. Product is to be returned with certificate of sterilization to Zimmer Product Service Department 1777 West Center St. Warsaw, IN 46580 or Zimmer International Logistics, Eschbach Germany for International Accounts. For questions regarding this recall call 574-372-4807.

Recalling firm

Firm: Zimmer, Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.

Timeline

Recall initiated: 2012-11-14
Posted by FDA: 2012-12-18
Terminated: 2014-04-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #114651. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.