BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAX PRI DCM TIB BRNG14X71/75MM

    MDR report key: 6901235 · Received September 28, 2017

    Report

    Report Number
    0001825034-2017-07531
    Event Type
    Injury
    Date Received
    September 28, 2017
    Date of Event
    July 19, 2017
    Report Date
    September 28, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-06762, 0001825034-2017-07525, 0001825034-2017-07531, 0001825034-2017-07540. CONCOMITANT MEDICAL PRODUCTS: BIOMET FINNED PRI STEM 40MM, CATALOG# 141314 LOT# 202100. MAXIM POR ANA PRI FML 65 LT, CATALOG # 140072, LOT # 258670. BIOMET ILOK PRI TIB TRAY 75MM, CATALOG # 141214, LOT # 212710. BIOMET ARCOM AP PAT W/WIRE 28MM, CATALOG # 11-150825, LOT # 044870. MAX PRI DCM TIB BRNG14X71/75MM, CATALOG # 11-146154, LOT # 353950. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO BEING DISCARDED. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PHOTOS. VISUAL INSPECTION OF THE PHOTOS CONFIRMS SEVERE WEAR AND FRACTURE OF THE TIBIAL AND THE BEARING COMPONENTS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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 APPROXIMATELY 10 YEARS AFTER THE PATIENT'S KNEE PROCEDURE A REVISION OCCURRED DUE TO EXTREME TIBIAL WEAR. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681876 MAX PRI DCM TIB BRNG14X71/75MM KNEE, PROSTHESIS JWH ZIMMER BIOMET, INC. 353950

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R