BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK GLENOID

    MDR report key: 1924743 · Received December 9, 2010

    Report

    Report Number
    1822565-2010-01316
    Event Type
    Injury
    Date Received
    December 9, 2010
    Report Date
    November 12, 2010
    Manufacturer
    ZIMMER INC
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: NO X-RAYS OR OPERATIVE NOTES WERE RETURNED FOR REVIEW. PT INFORMATION SUCH AS ACTIVITY LEVEL IS UNK. IMPLANT WEAR MAY BE ATTRIBUTED TO THIRD BODY WEAR OR EXTREME LOADS. HOWEVER, BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE CANNOT BE ASCERTAINED AT THIS TIME. EVALUATION CODES: 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 SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE RE-OPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2007 AND THAT THE PT WAS REVISED FOR WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK GLENOID SHOULDER PROSTHESIS HSD ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention