BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER TM REVERSE HUMERAL STEM SPACER

    MDR report key: 2921481 · Received January 9, 2013

    Report

    Report Number
    1822565-2013-00050
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    November 30, 2012
    Report Date
    December 10, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: THE REPORTED DISLOCATION IS MOSTLY DUE TO POSTOPERATIVE JOINT LAXITY OR INADEQUATE RANGE OF MOTION ASSESSMENT. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVALUATION: 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 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 WAS REVISED DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11757 ZIMMER TM REVERSE HUMERAL STEM SPACER HSD ZIMMER, INC. 62078466

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention CATALOG #00434903603, LOT # 61984222| ZIMMER TM REVERSE SHOULDER POLY LINER: