BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR ILOK FEM-RT 67.5

    MDR report key: 8288835 · Received January 30, 2019

    Report

    Report Number
    0001825034-2019-00284
    Event Type
    Injury
    Date Received
    January 30, 2019
    Date of Event
    July 6, 2018
    Report Date
    July 31, 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
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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 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 · 0

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

    Additional Manufacturer Narrative · 1

    CONSUMER, LEGAL. CONCOMITANT MEDICAL PRODUCTS: PN: 402282, COBALT HV BONE CEMENT 40G, LN: 604360; PN: 402282, COBALT HV BONE CEMENT 40G, LN: 176790; PN: 42-422561, SIG TKA GDE/MDL SET 04-05, LN: 112561; PN: 11-150826, BMET ARCOM AP PAT W/WIRE 31MM, LN: 427700; PN: EP-183442, E1 VNGD CR TIB BRG 71/75X12, LN: 533490; PN: 141224, BIOMET CC I-BEAM TRAY 75MM, LN: J3224838; DJO COBALT HV BONE CEMENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 1 YEAR POST-IMPLANTATION DUE TO PAIN AND LOOSENING. THE FEMORAL COMPONENT WAS REVISED. THE OPERATIVE REPORT NOTES THAT WHEN THE FEMORAL COMPONENT WAS TAPPED ON WITH A ONE PUNCH AND MALLET, THERE WAS BUBBLING CONSISTENT WITH LOOSENESS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81744 VANGUARD CR ILOK FEM-RT 67.5 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 660700

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R