BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN FEMORAL COMPONENT

    MDR report key: 1892705 · Received October 28, 2010

    Report

    Report Number
    1822565-2010-01033
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER DEVICE USED: CATALOG # UNK, UNK STEMMED TIBIA, LOT # UNK. EVALUATION SUMMARY: THERE WAS NO INFORMATION GIVEN ON THE PRODUCT NUMBER OR LOT NUMBER FOR ANY OF THE COMPONENTS. NO IMPLANTS, X-RAYS, OR ANY OTHER INFORMATION WAS RETURNED FOR EVALUATION AND THEREFORE, NO FURTHER ANALYSIS CAN BE DONE ON THE COMPLAINT. WITHOUT ADDITIONAL INFORMATION, A ROOT CAUSE 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 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 WAS REVISED FOR LOOSENING. THE DEVICE WAS IMPLANTED IN 1999.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention