Medical products and therapy date detail of product: item number 0100214052 item name metasul durom, component for acetabulum, uncemented, 52¸ 46, code l lot # 2267929.Item number 0100181460 item name metasul ldh, head, 46, code l, taper 18/20 lot # 2276764.Item number 290039080 item name cls spotorno, stem, 135, uncemented, 8.0, taper 12/14 lot # 2278300.The manufacturer did not receive devices or x-rays for review.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.Based on an extensive investigation of events reported from several user facilities outside the usa, zimmer identified that the most probable cause for the outcome observed was a loose or unstable cup that resulted from use of surgical techniques not consistent with the manufacturer's recommendations.As a corrective action, a retraining program for users outside the usa was initiated in november 2009 and reported to the national competent authorities as required.The durom cup reported in this case is not marketed in the usa.A similar cup, compatible with the metasul ldh femoral head, is cleared in the usa and a corrective action for this product was reported to the fda in july 2008 as notification z-2415/2426-2008.No further investigation required as this issue is known and addressed in cp00000620 (error pattern: potential early revision of the acetabular component due to loosening, implant migration or unresolved pain, higher ion release).At least one of these error patterns is observed in this event.Should any additional information that changes the assessment become available to us, since this case is related to the issues for which zimmer implemented a corrective action there will be no further investigation.Therefore, zimmer (b)(4) considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
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