BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS TIBIAL POLY BEARING 14MM

    MDR report key: 18602356 · Received January 29, 2024

    Report

    Report Number
    0001825034-2024-00186
    Event Type
    Injury
    Date Received
    January 29, 2024
    Date of Event
    August 24, 2011
    Report Date
    February 15, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    K052685
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS IDENTIFIED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THIS COMPLAINT HAS BEEN REPORTED UNDER 0001825034-2024-00183.

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2024-00183, 0001825034-2024-00184, 0001825034-2024-00185. D10 MEDICAL PRODUCTS: OSS POLY TIBIAL BUSHING CATALOG#: 150476 LOT#: NI, OSS POLY LOCK PIN CATALOG#: 150478 LOT#: NI, OSS POLY FEMORAL BUSHINGS CATALOG#: 150477 LOT#: NI , CUSTOM COMPRESS OSS BIJ DEVICE CATALOG#: NI LOT#: NI , UNKNOWN PALACOS CEMENT CATALOG#: NI LOT#: NI , OSS MOD TIB BASEPLATE 79MM CATALOG#: 150424 LOT#: NI , OSS CEMENTED IM STEM 13MMX90MM CATALOG#: 150362 LOT#: NI, OSS REINFORCED YOKE CATALOG#: 150493 LOT#: NI , OSS 7CM SEGMENTAL FEMORAL RT CATALOG#: 150354 LOT#: NI , OSS AXLE CATALOG#: 150480 LOT#: NI. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS IDENTIFIED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THIS COMPLAINT HAS BEEN REPORTED UNDER 0001825034-2024-00183.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY THREE YEARS POST-IMPLANTATION 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
    1250786 OSS TIBIAL POLY BEARING 14MM PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Male Required Intervention| H SEE H10.