BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APR HIP SYSTEM ENHANCED-ACETABULAR INSERT

    MDR report key: 1013956 · Received March 14, 2008

    Report

    Report Number
    1822565-2008-00105
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Date of Event
    May 2, 2006
    Report Date
    July 26, 2007
    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

    EVAL SUMMARY: THE STANDARD POLY LINER WAS IMPLANTED FOR APPROX 10 YEARS AND 6 MONTHS. THE DEVICE IS STILL IN-VIVO, AND IT APPEARS FROM THE PER THAT THE POLY HAS WORN BY 1.5 MM. X-RAYS/PARTS ARE NOT AVAILABLE FOR REVIEW. PT DETAILS LIKE, WEIGHT NOW AND DURING IMPLANT, ACTIVITY LEVEL, AGE, BUILD ARE NOT AVAILABLE. IT IS NOT POSSIBLE TO DETERMINE EXACT CAUSE OF CURRENT SITUATION WITH AVAILABLE INFO. EVALUATION: 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 INFO 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. IN 2006, IT IS REPORTED THAT THERE IS 1.5MM POLY WEAR ON THE DEVICE. THE PT HAS NOT BEEN REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APR HIP SYSTEM ENHANCED-ACETABULAR INSERT HIP PROSTHESIS KWB ZIMMER, INC. NA 1240262

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR