BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER MOST KNEE

    MDR report key: 2082930 · Received May 3, 2011

    Report

    Report Number
    1822565-2011-01106
    Event Type
    Injury
    Date Received
    May 3, 2011
    Report Date
    April 4, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: PT DEMOGRAPHICS AND SURGICAL NOTES ARE UNAVAILABLE. IT IS UNK WHETHER THE DEVICES IMPLANTED ARE OF PROPER COMBINATION. POST-OP X-RAYS RETURNED DO NOT INDICATE ANY ABNORMALITY WITH THE FIXATION OF DEVICES. THERE HAVE BEEN NO PREVIOUS COMPLAINTS REPORTED ON MOST DISTAL FEMUR IMPLANTS. WITH THE AVAILABLE INFO, THE PT'S PAIN AT THE TROCHLEAR REGION CANNOT BE DETERMINED. 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 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 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 RAISED RIDGES IN THE TROCHLEAR GROOVE ARE BINDING WITH SOFT TISSUE BETWEEN THE RIDGES AND THE PATELLA. THIS IS CAUSING THE PT QUITE A BIT OF PAIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other