BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER KNEE IMPLANT

    MDR report key: 2082902 · Received May 3, 2011

    Report

    Report Number
    1822565-2011-01092
    Event Type
    Injury
    Date Received
    May 3, 2011
    Report Date
    December 18, 2010
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: PART AND LOT NUMBERS WERE NOT PROVIDED; THEREFORE, PRODUCT COMPATIBILITY CANNOT BE CONFIRMED. NEITHER X-RAYS OR OPERATIVE NOTES WERE PROVIDED. AS SUCH, THE SURGICAL TECHNIQUE CANNOT BE REVIEWED AND THE IMPLANT CONSTRUCT CANNOT BE ANALYZED RADIOGRAPHICALLY. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, AND TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNKNOWN. BASED ON THE AVAILABLE INFORMATION, 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 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 WAS REPORTED THAT THE PATIENT'S RIGHT KNEE SCRAPES AND FEELS LOOSE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other