BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS SEGMENTAL STACKING ADAPTER

    MDR report key: 9739742 · Received February 21, 2020

    Report

    Report Number
    0001825034-2020-00836
    Event Type
    Injury
    Date Received
    February 21, 2020
    Date of Event
    January 30, 2012
    Report Date
    February 21, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00880304239999
    PMA / PMN Number
    K011455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2016-03780. 0001825034-2019-04426. 0001825034-2019-04427. 0001825034-2019-04425. 0001825034-2019-04428. 0001825034-2019-04429. 0001825034-2019-04430. 0001825034-2019-04431. 0001825034-2019-04432. 0001825034-2019-04433. CONCOMITANT MEDICAL PRODUCTS: 150410, OSS TIBIAL POLY BEARING 12MM, LOT # 520820, 150467 OSS 9CM DIAPHYSEAL SEGMENT, LOT # 289150, 150476, POLY TIBIAL BUSHING, LOT # 143560, 150477, POLY FEMORAL BUSHING, LOT # 050320, 150478, OSS POLY LOCK PIN, LOT # 143560, 150465, OSS 5 CM DIAPHYSEAL SEGMENT, LOT # 508870, 150479, OSS REINFORCED YOKE, LOT # 125790, 150367, OSS CEMENTED IM STEM, LOT # 240470, 150480, OSS AXLE, LOT #178390. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. MEDICAL RECORDS WERE NOT PROVIDED. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 7 YEARS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202075 OSS SEGMENTAL STACKING ADAPTER PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 005490 00880304239999

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R