BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VG DA 360 O/S TIB TRAY COCR 67

    MDR report key: 5638251 · Received May 6, 2016

    Report

    Report Number
    0001825034-2016-01507
    Event Type
    Injury
    Date Received
    May 6, 2016
    Date of Event
    June 6, 2016
    Report Date
    October 24, 2016
    Manufacturer
    BIOMET UK LTD.
    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
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. 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 REPORT IS NUMBER 3 OF 6 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-01505-01507 / 01509-01511). DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. 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 K093293.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. (B)(4). REVIEW OF DEVICE HISTORY AND MANUFACTURING RECORDS FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. VISUAL INSPECTION SHOWED EVIDENCE OF SCRATCHES MOST LIKELY FROM EXTRACTION IS NOTED ON THE DEVICE. ROOT CAUSE OF THE EVENT WAS MOST LIKELY DUE TO THE SET SCREW NOT BEING FULLY SEATED; HOWEVER, A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED WITHOUT ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.(B)(4).

    Description of Event or Problem · 1

    A LEFT KNEE REVISION HAS BEEN INDICATED DUE TO PAIN, TIBIAL FRACTURE, AND LOOSENING BETWEEN THE DISTAL STEM AND OFFSET ADAPTER. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY THREE MONTHS POST-IMPLANTATION DUE TO PAIN, TIBIAL FRACTURE, AND LOOSENING BETWEEN THE DISTAL STEM AND OFFSET ADAPTER. DURING THE PROCEDURE, THE TIBIAL TRAY, STEM AND BEARING WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293001 VG DA 360 O/S TIB TRAY COCR 67 PROSTHESIS, KNEE JWH BIOMET UK LTD. N/A 3482041

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention