BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER ACETABULAR LINER

    MDR report key: 2212601 · Received August 11, 2011

    Report

    Report Number
    1822565-2011-01866
    Event Type
    Injury
    Date Received
    August 11, 2011
    Report Date
    July 15, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: DEVICE WAS IN VIVO FOR APPROX 10 YEARS AND 1 MONTH AT THE TIME THAT THE EVENT WAS REPORTED. DEVICE WAS NOT AVAILABLE BECAUSE IT MAY REMAIN IMPLANTED; THEREFORE CONDITION IS UNK. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENT WAS IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENT SUCH AS ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNK. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. EVAL: 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 ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT OSTEOLYSIS HAS BEEN OBSERVED IN STEM ZONES 1 AND 7 BY GRUEN CLASSIFICATION AND CUP ZONES 2 AND 3 BY DELEE AND CHARNLEY CLASSIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ZIMMER ACETABULAR LINER HIP PROSTHESIS KWB ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other