BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER LINER

    MDR report key: 1960957 · Received January 11, 2011

    Report

    Report Number
    1822565-2011-00046
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    July 3, 2010
    Report Date
    December 15, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: SURGICAL NOTES FROM FEBRUARY WERE REVIEWED AND DID NOT REVEAL ANY COMPLICATIONS. SURGICAL NOTES FROM JULY WERE NOT SUBMITTED FOR REVIEW. X-RAYS OF THE PATIENT'S CONDITION WERE ALSO NOT RETURNED. IT IS POSSIBLE THAT THE CERAMIC DEBRIS NOTED WITHIN SEVERAL POST OP REPORTS COULD HAVE BEEN A CONTRIBUTING FACTOR; HOWEVER, WITH THE INFO PROVIDED, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. DUE TO INSUFFICIENT INFO, FURTHER ANALYSIS IS NOT POSSIBLE. EVAL: 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 ADD'L 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 PATIENT WAS REVISED FOR PAIN, TENDERNESS, LIMPING, AND CLICKING AND DEBRIS REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ZIMMER LINER HIP PROSTHESIS JDI ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention