BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER BIPOLAR COCR SHELL

    MDR report key: 3022664 · Received March 22, 2013

    Report

    Report Number
    1822565-2013-00525
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    January 10, 2013
    Report Date
    February 24, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT WAS NOTED THAT THE SURGEON STATED THAT THE PATIENT'S BONE QUALITY WAS POOR. NEITHER X-RAYS NOR OPERATIVE REPORTS WERE RETURNED FOR REVIEW, THEREFORE COMPONENT FIT AND ORIENTATION PER THE SURGICAL TECHNIQUE IS UNKNOWN. IN GENERAL, PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS INCLUDE: AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY. IT IS UNKNOWN IF ANY UNREPORTED TRAUMATIC EVENT MAY HAVE CONTRIBUTED TO THE COMPONENT MIGRATION, WHEREBY POOR ALIGNMENT CAUSED LINER WEAR THAT FURTHER LED TO OSTEOLYSIS. WITH THE INFORMATION PROVIDED, AN EXACT CAUSE CANNOT BE DETERMINED. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY DEVIATIONS OR ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO IMPLANT MIGRATION AND OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119377 ZIMMER BIPOLAR COCR SHELL KWY ZIMMER, INC. 61260658

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATALOG #440526044, LOT #61008804| ZIMMER TOTAL HEAD NEUTRAL NECK| CATALOG #721026000, LOT #61270792| ZIMMER DURASUL BIPOLAR INSERT