BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER KNEE

    MDR report key: 2041066 · Received March 29, 2011

    Report

    Report Number
    1822565-2011-00762
    Event Type
    Injury
    Date Received
    March 29, 2011
    Report Date
    March 1, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NEITHER X-RAYS NOR OPERATIVE NOTES WERE PROVIDED. AS SUCH, THE SURGICAL TECHNIQUE CANNOT BE REVIEWED AND THE IMPLANT CONSTRUCT CANNOT BE ANALYZED RADIOGRAPHICALLY. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, AND TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNK. BASED ON THE AVAILABLE INFO, AN EXACT CAUSE FOR THE REPORTED CONDITION CANNOT BE DETERMINED. 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 THE DEVICE WAS IMPLANTED IN 2008, AND THAT THE PT IS EXPERIENCING PAIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other