BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS CEMENTED IM STEM 14X150

    MDR report key: 9962411 · Received April 15, 2020

    Report

    Report Number
    0001825034-2020-01649
    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

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. X-RAY REVIEW INDICATES THERE IS A PERIPROSTHETIC FRACTURE OF THE DISTAL FEMUR WITH MODERATE FRACTURE DISPLACEMENT. KNEE ARTHROPLASTY COMPONENTS ARE MAINTAINED IN ALIGNMENT WITHOUT DISLOCATION. BONE IS OSTEOPENIC. 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). CONCOMITANT MEDICAL PRODUCTS: OSS 7CM SEG ELLIPT FEMORAL LT CATALOG # 150357 LOT # 598880, 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: 0001825034-2020-01648. 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
    425564 OSS CEMENTED IM STEM 14X150 PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 183830

    Patients

    Seq Age Sex Outcome Treatment
    1