BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APR HIP SYSTEM ENHANCED ACETABULAR INSERT

    MDR report key: 1082146 · Received July 25, 2008

    Report

    Report Number
    1822565-2008-00448
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    July 10, 2007
    Report Date
    July 1, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WEAR PERFORMANCE OF A COMPONENT IS DEPENDENT ON A VARIETY OF FACTORS, SUCH AS PATIENT ACTIVITY LEVEL AND SHELL ORIENTATION. THE LINER WAS IMPLANTED FOR 10 YEARS WITH 1MM REPORTED WEAR FOR NON-CROSSLINKED POLYETHYLENE. INFORMATION WAS NOT PROVIDED ON THE TYPE OF ALLEGED WEAR OR LOCATION, I.E. BETWEEN THE LINER AND FEMORAL HEAD OR LINER AND FEMORAL NECK (IMPINGEMENT) OR LINER AND SHELL (BACKSIDE WEAR). CAUSE CANNOT BE DEFINITIVELY DETERMINED. NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. 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 INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 1997. ABOUT 3 MONTHS PRIOR, THE SITE REPORTED 1MM POLYWEAR. IT IS UNKNOWN IF A REVISION SURGERY WILL OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APR HIP SYSTEM ENHANCED ACETABULAR INSERT HIP PROSTHESIS KWB ZIMMER, INC. NA 1246271

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR