BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM CONSTR HD 36MM T1 -6MM

    MDR report key: 8716300 · Received June 20, 2019

    Report

    Report Number
    0001825034-2019-02674
    Event Type
    Injury
    Date Received
    June 20, 2019
    Date of Event
    August 25, 2014
    Report Date
    June 20, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWZ
    PMA / PMN Number
    K030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES - REGEN/RNGLC+ MULTI 54MM SZ 23, # ITEM: PT-106054, LOT: 641640; FREEDOM CONSTRAIN LINER, # ITEM: 11-107022, LOT: 436220; TI LOW PROFILE SCREW, # ITEM: 103534, LOT: 925870; TI LOW PROFILE SCREW, # ITEM: 103534, LOT: 61190; TAPERLOC MICRO LAT FEMORAL, # ITEM: 15-103207, LOT: 413780; TI LOW PROFILE SCREW, # ITEM: 103531, LOT: 171810. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. XRAYS DEMONSTRATE PROTRUSION, LOOSENING, AND MIGRATION OF THE ACETABULAR COMPONENT. LARGE EFFUSION NOTED WITH DISRUPTION OF POSTERIOR EXTERNAL ROTATOR REPAIR. FEMORAL COMPONENT NOT LOOSE BUT REMOVED DUE TO LEG LENGTH INEQUALITY. UNABLE TO REMOVE COMPONENT, SO TROCHANTERIC OSTEOTOMY WAS PERFORMED. CABLES USED TO STABILIZE OSTEOTOMY. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT HIP REVISION DUE TO PAIN, DISLOCATION, LOOSENING AND MIGRATION OF ACETABULAR COMPONENT FIVE MONTHS POST IMPLANTATION. DURING SURGERY, LARGE EFFUSION NOTED WITH DISRUPTION OF POSTERIOR EXTERNAL ROTATOR REPAIR FEMORAL COMPONENT NOT LOOSE BUT REMOVED DUE TO LEG LENGTH INEQUALITY. UNABLE TO REMOVE COMPONENT, SO TROCHANTERIC OSTEOTOMY WAS PERFORMED CABLES USED TO STABILIZE OSTEOTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511170 FREEDOM CONSTR HD 36MM T1 -6MM PROSTHESIS HIP KWZ ZIMMER BIOMET, INC. N/A 340950

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R