BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER KNEE

    MDR report key: 1131891 · Received August 19, 2008

    Report

    Report Number
    1822565-2008-00530
    Event Type
    Injury
    Date Received
    August 19, 2008
    Report Date
    July 21, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    WE COULD NOT OBTAIN A COMPLETE CATALOG NUMBER; THEREFORE, A BASELINE REPORT CANNOT BE FILED. EVAL SUMMARY: NO PRODUCT RETURNED FOR EVAL ALSO X-RAYS ARE NOT AVAILABLE FOR REVIEW. THE ITEM NUMBER AND LOT NUMBER OF THE DEVICE IS NOT KNOWN. THE MANUFACTURING RECORDS COULD NOT BE REVIEWED AS THE LOT NUMBER IS NOT AVAILABLE. NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO 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 CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED. IMPLANT AND EXPLANT DATES ARE UNKNOWN. REASON FOR REVISION IS UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R