BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS (TM) REINFORCED YOKE

    MDR report key: 8276975 · Received January 25, 2019

    Report

    Report Number
    0001825034-2019-00315
    Event Type
    Injury
    Date Received
    January 25, 2019
    Date of Event
    February 1, 2007
    Report Date
    March 18, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REVIEW OF THE EVENT, IT HAS BEEN DETERMINED THAT THIS EVENT WAS A RESULT OF A COINCIDING PROCEDURE, AND WILL BE REPORTED UNDER MEDWATCH 0001825034-2019-00295. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: OSS FEMORAL, CATALOG #: 150357, LOT #: 236000. OSS AXLE, CATALOG #: 150480, LOT #: 786840. OSS TIBIAL BEARING, CATALOG #: 150410, LOT #: 875680. OSS POLY TIBIAL BUSHING, CATALOG #: 150476, LOT #: 689570. OSS POROUS IM STEM, CATALOG #: 150403, LOT #: 596730. OSS PROXIMAL TIBIA, CATALOG #: 150805, LOT #: 161380. OSS POLY LOCK PIN, CATALOG #: 150478, LOT #: 855320. OSS POLY FEMORAL BUSHINGS, CATALOG #: 150477, LOT #: 745350. CUSTOMER HAS INDICATED PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP MDR WILL BE REPORTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-00311, 0001825034-2019-00312, 0001825034-2019-00313, 0001825034-2019-00314, 0001825034-2019-00316, 0001825034-2019-00317, 0001825034-2019-00318, 0001825034-2019-00319. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. DEVICE REMAINS IMPLANTED IN PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY STAGE II REIMPLANTATION AND HAD AN INTRAOPERATIVE BLOOD LOSS OF 1000 ML. SUBSEQUENTLY, PATIENT WAS TRANSFUSED WITH TWO UNITS OF BLOOD FIVE DAYS POST-OPERATIVELY FOR ACUTE POSTOPERATIVE BLOOD LOSS ANEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69974 OSS (TM) REINFORCED YOKE PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 063820

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention