BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM-TIBIAL BEARING 10MM THICK X 71/75 WIDE

    MDR report key: 6472409 · Received April 7, 2017

    Report

    Report Number
    0001825034-2017-02439
    Event Type
    Injury
    Date Received
    April 7, 2017
    Date of Event
    March 23, 2017
    Report Date
    August 4, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET MAXIM ILOK ANA PRI FML 65 RT CATALOG: 140012 LOT: 483690 BIOMET BIOMET ILOK PRI TIB TRAY 71MM CATALOG: 141213 LOT: 116600 BIOMET BIOMET FINNED PRI STEM 40MM CATALOG: 141314 LOT: 363800 BIOMET BMET ARCOM AP PAT W/WIRE 34MM CATALOG: 11-150828 LOT: 437660. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. 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. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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. 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 PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO WEAR OF THE TIBIAL BEARING 13 YEARS POST IMPLANTATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256188 MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM-TIBIAL BEARING 10MM THICK X 71/75 WIDE PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 139860

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R