BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD DA360 TIBIAL BEARING ARCOM 63/67X18

    MDR report key: 6631105 · Received June 9, 2017

    Report

    Report Number
    0001825034-2017-03751
    Event Type
    Injury
    Date Received
    June 9, 2017
    Date of Event
    March 16, 2017
    Report Date
    August 25, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PSEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PT AGE: - DATE OF BIRTH - (B)(6). UDI# - (B)(4). CONCOMITANT MEDICAL PRODUCTS: - VNGD SSK 360 R FEM 75MM, CATALOG #: 185268, LOT #: 2771913. BMT SMOOTH KNEE STEM 14X80, CATALOG #: 145024, LOT #: 793510. VG 360 UNIV PST FM AUG 75X5, CATALOG #: 185348, L #: 157630 (X2). VG 360 DST FM AG 75X5 RL/LM, CATALOG #: 185308, L #: 030310. VG DA 360 O/S TIB TRAY COCR 67, CATALOG #: 161429, L #: 3457952. BMT SMOOTH KNEE STEM 12X80, CATALOG #: 145022, L #: 896220. BMT 360 TIB AUG 67X10MM, CATALOG #: 185232, L #: 409170 (X2). PALACOS CEMENT, CATALOG #: UNKNOWN, L #: UNKNOWN. REPORT SOURCE - (B)(6). PMA 510(K) - THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET UK AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510K NUMBER K042757. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED, BUT THE DEVICE INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE COMPLETED.

    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 (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. 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 THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY ONE YEAR POST-IMPLANTATION DUE TO INSTABILITY. ALL COMPONENTS WERE REMOVED AND REPLACED. 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
    413172 VANGUARD DA360 TIBIAL BEARING ARCOM 63/67X18 KNEE PROSTHESIS JWH BIOMET ORTHOPEDICS 3428061

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R