BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITANIUM NEXGEN LCCL FEMORAL SZ C-LT

    MDR report key: 7802417 · Received August 21, 2018

    Report

    Report Number
    0001825034-2018-08384
    Event Type
    Injury
    Date Received
    August 21, 2018
    Date of Event
    July 30, 2018
    Report Date
    January 18, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT OPERATIVE NOTES WERE EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. PER THE OPERATIVE NOTES, THE SET SCREWS WERE COLD-WELDED IN THE FEMORAL IMPLANT. ONE OF THE TWO SCREWS WAS ABLE TO SCREWED WITH GREAT DIFFICULTY. THE SURGEON HAD TO HAMMER THE TWO COMPONENTS TOGETHER. THEY WERE FOUND TO BE STABLE AND THE PROCEDURE PROCEEDED. REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO DEVIATIONS OR ANOMALIES. ROOT CAUSE COULD NOT BE DETERMINED. 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 · 0

    IT WAS REPORTED THAT THE COLD WELD UNABLE TO DISENGAGE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET AND IS NOT CLEARED IN THE U.S., HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER K960279. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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 MEDIAL AND LATERAL SCREWS WERE STUCK IN THE FEMORAL SHAFT ENTRY AND IT WASN'T POSSIBLE TO SCREW THEM IN OR OUT EVEN FOR SEVERAL THREAD TURNS. THE ENTRIES WERE DAMAGED. THE ORIGINAL TORQUE WRENCH BROKE OFF WITHOUT HAVING AN EFFECT ON THE SCREWS. THE COMPONENT WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641250 TITANIUM NEXGEN LCCL FEMORAL SZ C-LT PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 169790

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other