BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK AVENIR BROACH

    MDR report key: 11251610 · Received January 29, 2021

    Report

    Report Number
    0001822565-2021-00261
    Event Type
    Injury
    Date Received
    January 29, 2021
    Date of Event
    September 29, 2020
    Report Date
    January 29, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ACETABULAR CUP ¿ 010000664, LOT 6800879; ACETABULAR LINER ¿ 30103606, LOT 64809001; FEMORAL HEAD ¿ 00877503602, LOT 3020552; FEMORAL STEM ¿ 00786401420, LOT 64243620. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OP NOTES. OPERATIVE NOTES WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL. DURING AN INITIAL RIGHT THA, A CALCAR FRACTURE WAS NOTICED WHILE BROACHING THE FEMUR. CERCLAGE WIRE WAS PLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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 A PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. DURING THE SURGERY, THE PATIENT EXPERIENCED AN INTRA-OPERATIVE BONE FRACTURE ABOVE THE CALCAR WHILE PREPPING THE FEMUR. PATIENT'S MEDICAL RECORDS NOTED THE FOLLOWING: SURGEON STATED THAT THEY BROACHED FROM A SIZE 9 TO SIZE 14. THE PATIENT WAS NOT STABLE AT 13, AND THERE WAS CLEARLY ROTATIONAL INSTABILITY, WHEN THE SURGEON WENT TO A 14, IT WAS EXTREMELY TIGHT. A SMALL CRACK WAS NOTICED ABOVE THE CALCAR, A LITTLE TRIANGULAR CRACK IN THE STANDARD PLACE THAT YOU WOULD SEE A PERIPROSTHETIC CRACK. THE SURGEON PLACED A CERCLAGE WIRE AROUND THE FEMUR, REMOVED THE BROACH AND STARTED RE-TAPPING. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146373 UNK AVENIR BROACH PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other