BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER SHOULDER

    MDR report key: 1990803 · Received February 8, 2011

    Report

    Report Number
    1822565-2011-00190
    Event Type
    Injury
    Date Received
    February 8, 2011
    Report Date
    January 10, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: IT IS NOT KNOWN AT THIS TIME IF THE PRODUCTS IMPLANTED WERE ZIMMER PRODUCTS. SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. 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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT IS PRESENTING WITH PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ZIMMER SHOULDER SHOULDER PROSTHESIS HSD ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other