BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ZIMMER FEMORAL COMPONENT

    MDR report key: 1932029 · Received November 30, 2010

    Report

    Report Number
    1822565-2010-01216
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Report Date
    November 3, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A HEALTH PROFESSIONAL WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: THE JOURNAL ARTICLE REPORTS A NONPROGRESSIVE FEMORAL RADIOLUCENCY UNDER THE ANTERIOR FLANGE OF THE FEMORAL COMPONENT. IMPLANTATION DATE IS UNK. DATE OF THE OBSERVED RADIOLUCENCY IS UNK. NEITHER X-RAYS NOR OPERATIVE NOTES WERE RETURNED FOR REVIEW. PT INFORMATION SUCH AS HEIGHT, WEIGHT, AND ACTIVITY LEVEL IS UNK. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE CANNOT BE ASCERTAINED AT THIS TIME. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO 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 INFORMATION, 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 SHOWED SIGNS OF FEMORAL RADIOLUCENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ZIMMER FEMORAL COMPONENT KNEE PROSTHESIS JWH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1