BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGC V2 INTERLOK TIB 8 X 79MM

    MDR report key: 5516226 · Received March 22, 2016

    Report

    Report Number
    3002806535-2016-00123
    Event Type
    Injury
    Date Received
    March 22, 2016
    Report Date
    February 23, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. 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. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K921182. EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DURING THE EVALUATION, THE POLYETHYLENE BEARING AND TIBIAL TRAY SHOWED EVIDENCE OF WEAR. ROOT CAUSE OF THE EVENT WAS MOST LIKELY ATTRIBUTED TO THIRD PARTY DEBRIS OR THE COMPONENT EXCEEDED SHELF LIFE; HOWEVER, A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER ADVERSE REACTIONS, NUMBER 4 STATES, "PARTICULATE WEAR DEBRIS AND DISCOLOURATION FROM METALLIC OR POLYETHYLENE COMPONENTS OF JOINTS IMPLANTS MAY BE PRESENT IN ADJACENT TISSUE OR FLUID. IT HAS BEEN REPORTED THAT WEAR DEBRIS MAY INITIATE A CELLULAR PROCESS RESULTING IN OSTEOLYSIS OR IT MAY BE PRESENT AS A RESULT OF LOOSENING OF THE IMPLANT." UNDER STERILITY, "DO NOT USE IMPLANTS AFTER EXPIRATION DATE." THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 3002806535-2015-00135 &3002806535-2016-00123).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY IN (B)(6) 2008. DURING THE PROCEDURE, EXPIRED PRODUCT WAS IMPLANTED. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2015 DUE TO WEAR OF THE POLYETHYLENE TIBIAL BEARING. THE TIBIAL TRAY, POLYETHYLENE BEARING AND FEMORAL WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174768 AGC V2 INTERLOK TIB 8 X 79MM PROSTHESIS, KNEE JWH BIOMET UK LTD. N/A 695153

    Patients

    Seq Age Sex Outcome Treatment
    1 Other