BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS 7CM SEG ELLIPT FEMORAL LT

    MDR report key: 9962406 · Received April 15, 2020

    Report

    Report Number
    0001825034-2020-01648
    Event Type
    Injury
    Date Received
    April 15, 2020
    Report Date
    May 15, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    K002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED. IT IS NOW VERIFIED THAT THIS DEVICE IS RELATED TO THE EVENT.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED. IT IS NOW VERIFIED THAT THIS DEVICE IS RELATED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: OSS CEMENTED IM STEM 14X150, CATALOG # 150368, LOT # 183830; OSS POLY LOCK PIN, CATALOG # 150478, LOT # 901600; OSS REINFORCED YOKE, CATALOG # 150493, LOT # 596490; OSS POLY TIBIAL BUSHING, CATALOG # 150476, LOT # 925750; OSS POLY FEMORAL BUSHINGS, CATALOG # 150477, LOT # 033310; OSS TIBIAL POLY BEARING 20MM, CATALOG # 150414, LOT # 076270; OSS AXLE, CATALOG # 150480, LOT # 831000; OSS NON-MOD TIB PLATE LONG 67, CATALOG # 150420, LOT # 632350. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2020-01649. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ORTHOPEDIC SALVAGE PROCEDURE. SUBSEQUENTLY, THE PATIENT HAS EXPERIENCED A BONE FRACTURE. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. ATTEMPT FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425350 OSS 7CM SEG ELLIPT FEMORAL LT PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 598880

    Patients

    Seq Age Sex Outcome Treatment
    1 Other