BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM GLENOSPHERE

    MDR report key: 1033389 · Received April 15, 2008

    Report

    Report Number
    1822565-2008-00177
    Event Type
    Injury
    Date Received
    April 15, 2008
    Report Date
    March 4, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KYM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: IT IS NOT KNOWN WHETHER OR NOT THE DEVICE WAS PROPERLY SEATED DURING THE INITIAL SURGERY. STRAIGHT-ON EXPOSURE OF THE GLENOID IS NECESSARY FOR BOTH PROPER REAMING AND COMPONENT INSERTION. THE USE OF BASE PLATE REAMER 2 (36MM OR 40MM) IS NEEDED TO REMOVE BONE AROUND THE BASE PLATE TO AVOID IMPINGEMENT WITH THE GLENOSPHERE. THE PROBABLE CAUSE APPEARS TO BE AN INTRA-OPERATIVE ERROR DURING PLACEMENT OF THE GLENOSPHERE. AN EXACT CAUSE CANNOT BE DETERMINED WITH CERTAINTY. EVAL: NO PRODUCT OR X-RAYS WERE RETURNED. 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 INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PT UNDERWENT TOTAL SHOULDER REPLACEMENT SURGERY. APPROX 2 WEEKS POST-OP, THE PT HAD A DISSOCIATION OF THE GLENOID SPHERE FROM THE GLENOID COMPONENT, APPROX 23 DAYS LATER, REVISION SURGERY OCCURRED. EXACT IMPLANT AND EXPLANT DATES ARE NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM GLENOSPHERE SHOULDER PROSTHESIS KYM ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R