BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER FEMORAL COMPONENT

    MDR report key: 2023309 · Received February 15, 2011

    Report

    Report Number
    1822565-2011-00612
    Event Type
    Injury
    Date Received
    February 15, 2011
    Report Date
    February 16, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: EXACT TIME IN-VIVO AT THE TIME OF REVISION IS UNK. NEITHER X-RAYS NOR OP-NOTES WERE PROVIDED. AS SUCH, IT IS UNK WHETHER OR NOT THE SURGICAL TECHNIQUE WAS FOLLOWED APPROPRIATELY. BASED ON THE AVAILABLE INFORMATION, AN EXACT CAUSE FOR THE REPORTED REVISION CANNOT BE DETERMINED. EVALUATION: 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 INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE REC'D, 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 LOOSENING OF THE FEMORAL COMPONENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention