BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHK SEGMENTAL SHORT YOKE

    MDR report key: 6151203 · Received December 7, 2016

    Report

    Report Number
    3002806535-2016-00882
    Event Type
    Injury
    Date Received
    December 7, 2016
    Date of Event
    March 30, 2017
    Report Date
    August 24, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    PNA
    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. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. ROOT CAUSE IS DETERMINED TO BE USE ERROR, AS INCOMPATIBLE DEVICES WERE UTILIZED IN COMBINATION TOGETHER. (B)(4). 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 IN (B)(64 MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K002757.

    Description of Event or Problem · 1

    DURING A REVISION FROM A COMPETITOR TOTAL KNEE TO AN ORTHOPEDIC SALVAGE SYSTEM, AN INCOMPATIBLE DEVICE WAS ASSEMBLED AND IMPLANTED WITH THE ORTHOPEDIC SALVAGE SYSTEM. NO REVISION OR PATIENT INJURY HAS BEEN REPORTED TO DATE AS A RESULT.

    Description of Event or Problem · 1

    DURING A REVISION FROM A COMPETITOR TOTAL KNEE TO AN ORTHOPEDIC SALVAGE SYSTEM, AN INCOMPATIBLE DEVICE WAS ASSEMBLED AND IMPLANTED WITH THE ORTHOPEDIC SALVAGE SYSTEM. PATIENT WAS SUBSEQUENTLY REVISED FIVE MONTHS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803878 RHK SEGMENTAL SHORT YOKE PROSTHESIS, HIP JDI BIOMET UK LTD. N/A 3708806

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other