BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS POLY BUMPER LOCK PIN

    MDR report key: 10527508 · Received September 14, 2020

    Report

    Report Number
    0001825034-2020-03497
    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
    K051479
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EXAMINATION OF THE RETURNED LOCK PIN FOUND SIGNS OF BEING IMPLANTED AND IS FRACTURED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.

    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: 0001825034-2020-03498. MEDICAL DEVICES: OSS TIBIAL POLY BEARING 18MM CATALOG#: 150413 LOT#: 389760; 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
    996210 OSS POLY BUMPER LOCK PIN PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 908890

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R