BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER PATELLA

    MDR report key: 2030606 · Received March 18, 2011

    Report

    Report Number
    1822565-2011-00677
    Event Type
    Injury
    Date Received
    March 18, 2011
    Report Date
    March 17, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: NEITHER X-RAYS NOR OP-NOTES WERE PROVIDED. AS SUCH, SURGICAL TECHNIQUE CANNOT BE REVIEWED. PT DEMOGRAPHICS SUCH AS AGE, HEIGHT, WEIGHT, AND ACTIVITY LEVEL WERE NOT PROVIDED. BASED UPON THE AVAILABLE INFO, THE CAUSE OF THE REPORTED CONDITION CANNOT BE DETERMINED. EVAL: 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. THIS MDR WAS IDENTIFIED DURING AN INTERNAL REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE, IS BEING FILED LATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT PRESENTED WITH PATELLAR CLUNK AND WAS SCHEDULED TO HAVE A SCOPE ONE ON (B)(6) 2010.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention