BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK ZIMMER KNEE

    MDR report key: 1081729 · Received July 25, 2008

    Report

    Report Number
    1822565-2008-00445
    Event Type
    Injury
    Date Received
    July 25, 2008
    Report Date
    June 25, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE COULD NOT OBTAIN A COMPLETE CATALOG NUMBER; THEREFORE, A BASELINE REPORT CANNOT BE FILED. EVAL SUMMARY: NO PRODUCT RECEIVED FOR EVAL. ALSO X-RAYS ARE NOT AVAILABLE FOR REVIEW. ITEM NUMBER AND THE LOT NUMBER ARE NOT KNOWN SO DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE CAUSE OF THE PROBLEM COULD NOT BE DEFINITELY DETERMINED DUE TO INSUFFICIENT INFO, HOWEVER, THE INJURY DUE TO PT FALL COULD BE A CONTRIBUTING FACTOR. H6: EVAL: NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRE FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. 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 2 WEEKS POST-OP FROM TOTAL KNEE REPLACEMENT, PT FELL AT NURSING HOME AND EXPERIENCED FEMUR PERI-PROSTHETIC FRACTURE. FEMUR WAS CONVERTED TO LCCK WITH TIBIAL STEM ALREADY IN PLACE. EXACT IMPLANT DATE IS UNK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R