BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VG DA 360 TIB BRG ARCM 79/83X14

    MDR report key: 5806347 · Received July 19, 2016

    Report

    Report Number
    0001825034-2016-02622
    Event Type
    Injury
    Date Received
    July 19, 2016
    Date of Event
    March 7, 2016
    Report Date
    June 9, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    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
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. (B)(6). (B)(4). THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 15 STATES, ¿INTEROPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ THIS PRODUCT IS NOT CLEARED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K093293.

    Additional Manufacturer Narrative · 1

    UDI# - (B)(4). CONCOMITANT MEDICAL PRODUCTS - VNGD SSK 360 R FEM 75MM, CATALOG 185268, LOT 3400701; BMT SMOOTH KNEE STEM 14X80, CATALOG 145024, LOT 303320; VG 360 DST FM AG 75X10 RL/LM, CATALOG 185388, LOT 008930; VG 360 UNIV PST FM AUG 75X10, CATALOG 185428, LOT 818310; VG 360 UNIV PST FM AUG 75X5, CATALOG 185348, LOT 029320; VG DA 360 O/S TIB TRAY COCR 79, CATALOG 161432, LOT 3431122; BIOMET SMOOTH KNEE STEMS 10X40, CATALOG 145000, LOT 226130; BMT 360 2.5MM OFFSET ADAPTER, CATALOG 185210, LOT 881840; UNKNOWN PALACOS BONE CEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ENROLLED IN A CLINICAL STUDY EXPERIENCED SWELLING, EFFUSION, PAIN AND INSTABILITY APPROXIMATELY 11 MONTHS POST-IMPLANTATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ENROLLED IN A CLINICAL STUDY EXPERIENCED SWELLING, EFFUSION, PAIN AND INSTABILITY AND UNDERWENT AN EXCHANGE OF THE TIBIAL BEARING APPROXIMATELY ONE YEAR POST IMPLANTATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457338 VG DA 360 TIB BRG ARCM 79/83X14 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 3407781

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other