BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER M/L TAPER FEMORAL STEM

    MDR report key: 3201659 · Received June 28, 2013

    Report

    Report Number
    1822565-2013-01042
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    December 15, 2010
    Report Date
    May 31, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: PRIMARY OPERATIVE NOTES HAVE BEEN RETURNED WHICH WERE UNREMARKABLE. THE PT WAS IMPLANTED WITH METAL-ON-METAL COMPONENTS. REVISION NOTES WERE PROVIDED WHICH NOTE THAT THE SURGEON BELIEVED THE PT WAS HAVING PAIN BECAUSE OF FIBROUS INGROWTH OF THE FEMORAL PROSTHESIS SECONDARY TO IMPAIRED VASCULAR SUPPLY IN THE EARLY POSTOPERATIVE PERIOD. THE STEM SHOWED NO POSTERIOR BONE ONGROWTH, PATCHY BONE ONGROWTH ANTERIORLY, AND SOME BONY ONGROWTH ALONG THE CALCAR PORTION OF THE STEM. DURING REMOVAL OF THE STEM WITH A SLAP HAMMER AN INCOMPLETE CRACK DEVELOPED IN THE CALCAR WHICH WAS TREATED BY PASSING TWO CIRCUMFERENTIAL CABLES AROUND THE PROXIMAL FEMUR. A CEMENTED FEMORAL COMPONENT WAS THEN IMPLANTED. FROM THE INFO PROVIDED, A DEFINITIVE CAUSE CANNOT BE DETERMINED. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE REC'D, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO FIBROUS INGROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296778 ZIMMER M/L TAPER FEMORAL STEM KWA ZIMMER, INC. 61172397

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention