BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPLASTY TIBIAL TRAYS- LOCKING BAR

    MDR report key: 6501109 · Received April 18, 2017

    Report

    Report Number
    0001825034-2017-02651
    Event Type
    Injury
    Date Received
    April 18, 2017
    Report Date
    June 1, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK063732
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    CMP-(B)(4). MEDICAL PRODUCT- MAX PS DCM TIB BRNG 12X63/67MM CATALOG # 11-146532 LOT # 183290, MAX ILK ANA OPEN PS FMRL 65 RT CATALOG # 145152 LOT # 780850, BMET ARCOM AP PAT W/WIRE 28MM CATALOG # 11-150825 LOT # 821740, BIOMET FINNED PRI STEM 40MM CATALOG # 141314 LOT # 652620, BIOMET ILOK PRI TIB TRAY 67MM CATALOG # 141212 LOT # 223760. IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-02650.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT MAY REQUIRE A REVISION PROCEDURE DUE TO UNKNOWN REASONS, HOWEVER, NO REVISION HAS BEEN REPORTED TO DATE. 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
    281346 MICROPLASTY TIBIAL TRAYS- LOCKING BAR PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 153240

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention