BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALL POLY PATELLA

    MDR report key: 11055416 · Received December 22, 2020

    Report

    Report Number
    0002648920-2020-00538
    Event Type
    Injury
    Date Received
    December 22, 2020
    Report Date
    February 25, 2021
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    UDI-DI
    00889024247635
    PMA / PMN Number
    K113369
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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. 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: FEMUR CEMENTED CRUCIATE RETAINING (CR) CATALOG # 42502006002 LOT # 64276519. TIBIA CEMENTED 5 DEGREE STEMMED CATALOG # 42532006402 LOT # 64075020. ARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT (UC) CATALOG # 42521200410 LOT # 64090936. PERSONA CEM FEM/CEM TIB/S CATALOG # 98-0002-400-00 LOT # UNKNOWN CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 3007963827-2020-00329, 3007963827-2020-00330, 3007963827-2020-00331.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN, ALIGNMENT ISSUES AND BROKEN BONE IN HER FOOT. 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
    1519308 ALL POLY PATELLA PROSTHESIS KNEE JWH ZIMMER MANUFACTURING B.V. N/A 64441505 00889024247635

    Patients

    Seq Age Sex Outcome Treatment
    1 Other