BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS TIBIAL AUGMENT BLOCK

    MDR report key: 6630543 · Received June 9, 2017

    Report

    Report Number
    0001825034-2017-03685
    Event Type
    Injury
    Date Received
    June 9, 2017
    Date of Event
    April 18, 2017
    Report Date
    June 7, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PT IDENTIFIER: - (B)(6). CONCOMITANT MEDICAL PRODUCT - OSS TIBIAL POLY BEARING 20MM, CATALOG#: 150414, LOT#: 358720; OSS POLY TIBIAL BUSHING, CATALOG#: 150476, LOT#:684430; OSS RESURFACING FEMORAL, CATALOG#: 150351, LOT#: 645100; OSS CEMENTED IM STEM, CATALOG#: 150362, LOT#: 216750; OSS TIBIAL BLOCK, CATALOG#: 150429, LOT#: 643590; OSS TIBIAL BLOCK, CATALOG#: 150430, LOT#: 106840; OSS POLY FEMORAL BUSHING, CATALOG#: 150477, LOT#: 236380; OSS POLY FEMORAL BUSHING, CATALOG#: 150477, LOT#: 795950; OSS POLY LOCK PIN, CATALOG#: 150478, LOT#: 482740; OSS AXLE, CATALOG#: 150480, LOT#: 333140; OSS REINFORCED YOKE, CATALOG#: 150493, LOT#: 761690. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED [HOSPITAL RETAINED] TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1825034-2016-05257, 1825034-2017-03685 AND 1825034-2017-03686.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION OF AN ORTHOPEDIC SALVAGE SYSTEM APPROXIMATELY FIFTEEN (15) MONTHS POST-IMPLANTATION DUE TO LOOSENING OF THE TIBIAL COMPONENT. THE TIBIAL BLOCKS AND STEM WERE REMOVED AND REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412891 OSS TIBIAL AUGMENT BLOCK PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 106840

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R