BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER TM REVERSE SHOULDER POLY LINER

    MDR report key: 2855499 · Received November 29, 2012

    Report

    Report Number
    1822565-2012-02435
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    November 5, 2012
    Report Date
    October 31, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE OPERATIVE NOTES OF THE PRIMARY SURGERY DO NO INDICATE ANYTHING OUT OF THE ORDINARY AND STATES THE JOINT HAD "EXCELLENT STABILITY AND MOBILITY." THE OPERATIVE NOTES FOR THE REVISION SURGERY INDICATE THE PATENT HAD "MARKED LAXITY" OF THE JOIN. AS A RESULT, A THICKER SPACER AND POLY LINER WERE USED DURING THE REVISION SURGERY TO TIGHTEN THE JOINT. THIS WOULD INDICATE THE REPORTED DISLOCATION WAS NOT THE RESULT OF THE IMPLANTS BUT A RELAXATION OF THE JOINT TENDONS. 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 OR 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 PATIENT WAS REVISED DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER TM REVERSE SHOULDER POLY LINER HSD ZIMMER, INC. 61984222

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention TM REVERSE HUMERAL STEM SPACER| CATALOG #00434903909, LOT #62127650