BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER TM REVERSE RETENTIVE POLY LINER

    MDR report key: 3022758 · Received March 22, 2013

    Report

    Report Number
    1822565-2013-00523
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    ZIMMER INC
    Product Code
    KWT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE SUPPLIED X-RAYS INDICATE A POSSIBLE REDUCTION IN THE GLENOID BONE ON THE SUPERIOR SIDE OF THE CONSTRUCT, HOWEVER THE SUPPLIED X-RAYS ARE NOT AT THE OPTIMAL ANGLE AND ADDITIONAL X-RAYS WOULD BE NEEDED TO CONFIRM. OPERATIVE NOTES HAVE BEEN REQUESTED BUT HAVE NOT BEEN PROVIDED. WITH THE SUPPLIED INFORMATION AN EXACT CAUSE FOR THE REPORTED PAIN CANNOT BE DETERMINED AT THIS TIME. 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. CONSIDER THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. THE PATIENT HAD EXPERIENCED A FALL PRIOR TO THE REVISION. ONLY THE LINER WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120835 ZIMMER TM REVERSE RETENTIVE POLY LINER KWT ZIMMER INC 61645764

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention