BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER TRABECULAR METAL REVERSE LINER

    MDR report key: 2960310 · Received February 8, 2013

    Report

    Report Number
    1822565-2013-00269
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 11, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO DEVICES WERE RETURNED, HOWEVER A PHOTO OF THE REVISED POLY LINER WAS PROVIDED. THE PHOTO DOES NOT INDICATE ANYTHING OUT OF THE ORDINARY. THE STERILIZATION PROCESS FOR ALL DEVICES PRODUCED AT ZIMMER ARE VALIDATED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL (SAL) OF 1.0 X 10 (-6) OR BETTER, AND ARE PROCESSED ACCORDING TO THE VALIDATED STERILIZATION PROCESS PARAMETERS AND MUST MEET ALL THE ACCEPTANCE CRITERIA BEFORE STERILITY RELEASE. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICE CAUSED OR CONTRIBUTED TO ANY PT INFECTION. CAUSE CANNOT BE DEFINITIVELY DETERMINED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. 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 INFORMATION 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 HAD A POLY EXCHANGE DUE TO INFECTION. THE PT ALSO HAD AN INCISION AND DRAINAGE AND REDUCTION OF JOINT DONE AT THIS TIME. X-RAYS TAKEN AT THE EMERGENCY ROOM SHOWED THE PT'S SHOULDER WAS DISLOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53437 ZIMMER TRABECULAR METAL REVERSE LINER HSD ZIMMER, INC. 62114035

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention