BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 T1 PPS HO 10X140MM 0MM T1

    MDR report key: 7428312 · Received April 13, 2018

    Report

    Report Number
    0001825034-2018-02555
    Event Type
    Injury
    Date Received
    April 13, 2018
    Date of Event
    March 4, 2018
    Report Date
    June 15, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK101086
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4) CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO UNKNOWN LOCATION OF DEVICE. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ITEM # 163662, TAPER ADAPTER, LOT # 165950, ITEM # EP-200144, BEARING, LOT # 203620, ITEM # 110024461, LINER, LOT # 075320, ITEM # 110010242, CUP, LOT # 6144222. REPORTED EVENT WAS CONFIRMED VIA OPERATIVE REPORT. REVISION OP NOTES ON MAR 5, 2018 SHOWS THAT THE PATIENT WAS BEARING FULL WEIGHT 2 WEEKS POST REVISION AND SHE FELT A POP AND THEN FELT IMMEDIATE PAIN. X-RAYS SHOWED A LEFT FEMUR FRACTURE EXTENDING INTO THE FEMORAL SHAFT WITH LOOSENING OF THE STEM. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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 A PATIENT UNDERWENT A REVISION AND OPEN REDUCTION INTERNAL FIXATION PROCEDURE APPROXIMATELY 1 MONTH POST IMPLANTATION DUE TO FEMORAL FRACTURE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270565 TPRLC 133 T1 PPS HO 10X140MM 0MM T1 HIP PROSTHESIS KWA ZIMMER BIOMET, INC. N/A 6151663

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R