BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER M/L TAPER FEMORAL STEM

    MDR report key: 3110968 · Received May 9, 2013

    Report

    Report Number
    1822565-2013-00777
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 12, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: EVALUATION OF THE PRE-OP X-RAY REVEALS THE STEM TO BE IN A VARUS POSITION. PHOTOS HAVE BEEN PROVIDED AND CONFIRM THE ALLEGED DESCRIPTION OF THE DEVICES. 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. 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 WAS BEING REVISED DUE TO DISLOCATION. DURING THE REVISION, A PSEUDOTUMOR WAS NOTICED. THE TRUNNION OF THE NECK HAD METALLOSIS AND THE STEM APPEARED TO BE WELL FIXED BUT THE PLACEMENT WAS IN VARUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204777 ZIMMER M/L TAPER FEMORAL STEM KWA ZIMMER, INC. 61241178

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention LOT #61053530| MANUFACTURED BY ZIMMER (B)(4)| VERSYS FEMORAL HEAD: CAT #0081803602, LOT#61275762| KINECTIV MODULAR NECK: CATALOG #00784802101,