BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIAL HEAD 32 M TAPER 12/14

    MDR report key: 3935944 · Received June 17, 2014

    Report

    Report Number
    9613350-2014-03614
    Event Type
    Other
    Date Received
    June 17, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 23, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE THE DEVICE SINCE THE DEVICE IS STILL INTACT AND IN USAGE. NO OTHER SOURCE DOCUMENTS WERE PROVIDED FOR REVIEW. THE LOT NUMBER WAS RECEIVED FOR THE DEVICE, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFIRMING. SHOULD ADDITIONAL INFO BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING SAMPLING POSITION, ANTERIOR DISLOCATION OF THE HIP JOINT, (ACCIDENTAL) DURING PULLING BACK OF THE THIGH, THE SAMPLING HEAD REMAINED VENTRAL FROM BONE PELVIS AND MUST BE RETRIEVED THROUGH A SEPARATE ACCESS (SECOND INCISION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356264 TRIAL HEAD 32 M TAPER 12/14 TRIAL HEAD 32 M TAPER 12/14 LXH ZIMMER GMBH NA 11.630007

    Patients

    Seq Age Sex Outcome Treatment
    1 Other