BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BMET REGENX PRI TIB TRAY 79MM

    MDR report key: 6425596 · Received March 22, 2017

    Report

    Report Number
    0001825034-2017-01982
    Event Type
    Injury
    Date Received
    March 22, 2017
    Date of Event
    February 20, 2017
    Report Date
    February 8, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBH
    PMA / PMN Number
    PK080361
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCT(S): ¿ VANGUARD LEFT FEMUR, CATALOG 183072, LOT 632490; BIOMET FINNED STEM, CATALOG 141314, LOT 779640; SERIES A PATELLA, CATALOG 184768, LOT 525160; VANGUARD TIBIAL BEARING, CATALOG 183460, LOT 556750. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2018-00766. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PHOTOS AND RADIOGRAPHS. PHOTOS PROVIDED SHOW MEDIAL POSTERIOR REGION FRACTURE OF THE TIBIAL TRAY AND SEVERE WEAR ON THE MEDIAL POSTERIOR REGION OF THE POLY. RADIOGRAPH REVIEW CONFIRMED FRACTURE OF THE TIBIAL PLATE AND LOOSENING REGIONALLY. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. 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 TOTAL LEFT KNEE REVISION PROCEDURE APPROXIMATELY THREE YEARS POST IMPLANTATION DUE TO A POSTERIOR MEDIAL FRACTURE OF THE TIBIAL TRAY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207545 BMET REGENX PRI TIB TRAY 79MM PROSTHESIS, KNEE MBH BIOMET ORTHOPEDICS 104960

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R