BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD OPTION HEAD

    MDR report key: 7756540 · Received August 7, 2018

    Report

    Report Number
    0001825034-2018-06153
    Event Type
    Injury
    Date Received
    August 7, 2018
    Date of Event
    July 8, 2013
    Report Date
    October 11, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    PK082996
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES PROVIDED. REVISION OP NOTE SHOWS ESTIMATED BLOOD LOSS 1700ML. THE PATIENT WAS REVISED DUE TO INCREASED PAIN, LEG LENGTH INEQUALITY, CHRONIC PERIPROSTHETIC FRACTURE WITH A GROSSLY LOOSE STEM. CERCLAGE CABLES PLACED TO REDUCE THE LESSER TROCHANTERIC CHRONIC FRACTURE. CUP AND LINER LEFT INTACT. FEMORAL HEAD/NECK AND STEM REPLACED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES PROVIDED. REVISION OP NOTE SHOWS ESTIMATED BLOOD LOSS 1700ML. THE PATIENT WAS REVISED DUE TO INCREASED PAIN, LEG LENGTH INEQUALITY, CHRONIC PERIPROSTHETIC FRACTURE WITH A GROSSLY LOOSE STEM. CERCLAGE CABLES PLACED TO REDUCE THE LESSER TROCHANTERIC CHRONIC FRACTURE. CUP AND LINER LEFT INTACT. FEMORAL HEAD/NECK AND STEM REPLACED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: G7 NEUTRAL LINER # ITEM 010000857 LOT 2921390, TAPERLOC STEM # ITEM 51-108060 LOT 2479105, CER OPTION TYPE 1 TAPER SLEVE # ITEM 650-1065 LOT 683160, G7 ACETABULAR SHELL # ITEM 010000663 LOT 2804310. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-06149, 0001825034-2018-06147 AND 0001825034-2018-06154. 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 ESTIMATED BLOOD LOSS WAS 1700 ML DURING REVISION DUE TO PERIPROSTHETIC FEMORAL FRACTURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598174 CER BIOLOXD OPTION HEAD PROSTHESIS HIP LZO ZIMMER BIOMET, INC. N/A 773770

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other