BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN TRABECULAR METAL REVERSE SHOULDER

    MDR report key: 2222847 · Received August 10, 2011

    Report

    Report Number
    1822565-2011-01831
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: 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. THE NOMINAL FIT OF THE IMPLANT TO THE BONE PREPARATION IS INTENDED TO PROVIDE AN INTERFERENCE FIT CONDITION TO PROVIDE MECHANICAL STABILITY IN THE ABSENCE OF BONE CEMENT. DEPENDING ON PT BONE QUALITY, AND THE AMOUNT OF BONE REMOVED, THE AMOUNT OF PRESS FIT MAYBE LESS THAN DESIRED. THE EXACT CAUSE CANNOT BE DETERMINED WITH CERTAINLY. 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 SURGEON WAS UNABLE TO ACHIEVE A PRESS-FIT WHILE INSERTING THE STEM. THE SURGEON WAS ABLE TO IMPLANT THE STEM BY USE OF CEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention