BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM CONSTRAINED LINER

    MDR report key: 7611334 · Received June 18, 2018

    Report

    Report Number
    0001825034-2017-09915
    Event Type
    Injury
    Date Received
    June 18, 2018
    Date of Event
    April 2, 2016
    Report Date
    August 9, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWZ
    PMA / PMN Number
    PK030047
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE EVENT IT WAS DETERMINED THAT THE COMPLAINT IS NOT REPORTABLE AND THE INITIAL REPORT IS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM # 22-301303, ITEM NAME, ARCOS CON SZ C STD, 60 MM HA, LOT / SOFTWARE RELEASE # 786450. ITEM # 22-300919, ITEM NAME ARCOS 19 X 190 MM SPL, TPR DIST HA, LOT / SOFTWARE RELEASE # 415840. ITEM # 11-107018, ITEM NAME FREEDOM CONSTR HD, 36 MM T1 STD, LOT / SOFTWARE RELEASE # 386980. ITEM # 11-107324, ITEM NAME FREEDOM STD FACE, LINER SZ 25, LOT / SOFTWARE RELEASE # 073060. (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. X-RAY REVIEW NOTED OVERALL FIT AND ALIGNMENT OF THE IMPLANTS IS APPROPRIATE. OSTEOPENIA IS PRESENT. FRACTURES ARE SEEN INVOLVING THE GREATER TROCHANTER, LESSER TROCHANTER AS WELL AS THE LATERAL CORTEX OF THE PROXIMAL TO MID FEMORAL DIAPHYSIS DISTAL TO THE THIRD CERCLAGE WIRE. THERE IS ALSO A SUGGESTED FRACTURE INVOLVING THE MEDIAL CORTEX OF THE PROXIMAL FEMORAL DIAPHYSIS IN BETWEEN THE 1ST AND SECOND CERCLAGE WIRE. THERE APPEARS TO BE POSSIBLE FRACTURE INVOLVING THE SUPERIOR CERCLAGE WIRE MEDIALLY. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 INITIAL RIGHT HIP SURGERY ON AN UNKNOWN DATE AND WAS REVISED DUE TO OSTEOLYSIS AROUND A WELL-FIXED IMPLANT ON (B)(6) 2015. SUBSEQUENTLY THE PATIENT REPORTED SEVERE LIMP USING ONE CRUTCH FOR SUPPORT WALKING MAXIMUM DISTANCE AT FOLLOW UP VISIT ON (B)(6) 2016. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452093 FREEDOM CONSTRAINED LINER PROSTHESIS, HIP KWZ ZIMMER BIOMET, INC. N/A 073060

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R