BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER M/L MODULAR FEMORAL STEM

    MDR report key: 1830943 · Received September 7, 2010

    Report

    Report Number
    1822565-2010-00657
    Event Type
    Injury
    Date Received
    September 7, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 11, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO RETRIEVAL HAS BEEN FORWARDED TO ZIMMER FOR EVALUATION. NO X-RAYS, SURGICAL REPORT, MEDICAL HISTORY OF THE PATIENT, PATIENT ACTIVITY LEVEL AND WEIGHT HAS BEEN PROVIDED. IT IS ALSO NOT KNOWN WHETHER PROPER SURGICAL TECHNIQUE AND APPROPRIATE INSTRUMENTS WERE USED IN THE PRIMARY SURGERY OR NOT. STEM LOOSENING MAY BE CAUSED DUE TO ONE OF COMBINATION OF THE FOLLOWING FACTORS: HIGH ACTIVITY LEVEL OF THE PATIENT, IMPROPER SURGICAL TECHNIQUE, WEAR PARTICLES GENERATED FROM THE MATING BEARING SURFACES, OSTEOLYSIS. INADEQUATE INSTRUMENTATION HARBOURS THE RISK IF CANCELLOUS BONE IS LOST DUE TO GENEROUS RASPING/REAMING, HOWEVER, NO DEFINITE CAUSE ANALYSIS IS POSSIBLE BASED ON THE INFORMATION PROVIDED. EVALUATION: 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, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO STEM LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER M/L MODULAR FEMORAL STEM HIP PROSTHESIS KWY ZIMMER, INC. 61068324

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention