BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS TIBIAL POLY BEARING 18MM

    MDR report key: 10527505 · Received September 14, 2020

    Report

    Report Number
    0001825034-2020-03498
    Event Type
    Injury
    Date Received
    September 14, 2020
    Date of Event
    August 27, 2020
    Report Date
    January 25, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    K052685
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-03497. MEDICAL DEVICES: OSS POLY BUMPER LOCK PIN CATALOG#: 150510 LOT#: 908890, OSS REINFORCED YOKE CATALOG#: 150493 LOT#: 554600, OSS AXLE CATALOG#: 150480 LOT#: 286100, OSS POLY FEMORAL BUSHINGS CATALOG#: 150477 LOT#: 936210, OSS POLY TIBIAL BUSHING CATALOG#: 150476 LOT#: 233540. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A KNEE REVISION A FEW WEEKS AFTER A FALL DUE TO IMPLANT FRACTURE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995868 OSS TIBIAL POLY BEARING 18MM PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 389760

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10