BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET FIXED CRUCIATE TIBIAL PLATE WITH LOCKING BAR

    MDR report key: 8540507 · Received April 23, 2019

    Report

    Report Number
    0001825034-2019-01803
    Event Type
    Injury
    Date Received
    April 23, 2019
    Date of Event
    August 26, 2014
    Report Date
    December 19, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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 (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET FIXED CRUCIATE TIBIAL PLATE WITH LOCKING BAR CATALOG # 141235 LOT # 744910 VAN PS OPEN INTL FEM-LT 72.5 CATALOG # 183133 LOT # 904090, BMET ARCOM AP PAT W/WIRE 34MM CATALOG # 11-150828 LOT # 909580, BMET ARCOM AP PAT W/WIRE 34MM CATALOG # 11-150828 LOT # 881380, E1 VNGD PS TIB BRG 79/83X10 CATALOG # EP-183660 LOT # 889000, E1 VNGD PS TIB BRG 79/83X10 CATALOG # EP-183660 LOT # 383470. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2019-01806. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO PAIN, SWELLING AND LOOSENING OF THE TIBIAL PLATE. ATTEMPT FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334199 BIOMET FIXED CRUCIATE TIBIAL PLATE WITH LOCKING BAR KNEE PROSTHESIS JWH ZIMMER BIOMET, INC. N/A 905260 

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R