BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS REINFORCED YOKE

    MDR report key: 10454778 · Received August 26, 2020

    Report

    Report Number
    0001825034-2020-03363
    Event Type
    Injury
    Date Received
    August 26, 2020
    Date of Event
    July 6, 2020
    Report Date
    December 28, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    UDI-DI
    00880304240094
    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 RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT SHOULD BE VOIDED.

    Description of Event or Problem · 0

    THE SALES REP CONFIRMED THE LOCK PIN FRACTURED AND NOT THE YOKE. UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: 150392 - STEM - 987470; 150351 - FEMORAL - 289560; UNKNOWN POLY; 00998604020 - TREPHINE - 7198327. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2020 - 02876

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO FEMORAL STEM AND HINGE POST FRACTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919468 OSS REINFORCED YOKE PROSTHEIS, KNEE KRO ZIMMER BIOMET, INC. N/A 113530 00880304240094

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10.