BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMUR CEMENTED POSTERIOR STABILIZED (PS) STANDARD RIGHT SIZE 7

    MDR report key: 6377882 · Received March 3, 2017

    Report

    Report Number
    3007963827-2017-00019
    Event Type
    Injury
    Date Received
    March 3, 2017
    Date of Event
    December 2, 2016
    Report Date
    April 19, 2017
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    JWH
    PMA / PMN Number
    PK113369
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED ON THIS FORM WAS PREVIOUSLY SUBMITTED UNDER MANUFACTURING REPORT NUMBER 3007963827-2016-00073.

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: PERSONA STEMMED TIBIAL TRAY CATALOG 42532007502 LOT 62676445; TIBIAL ARTICULATING SURFACE CATALOG 42521400110 LOT 6231443; PATELLA CATALOG 42540000038 LOT 62113096. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 3007963827-2017-00019 / 2648920-2017-00167).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BONE SCAN EVIDENCED INCREASED RADIOLUCENCY AROUND THE PATIENT¿S FEMORAL AND TIBIAL COMPONENTS. AN ARTHROSCOPY WAS PERFORMED APPROXIMATELY THREE YEARS POST IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160690 FEMUR CEMENTED POSTERIOR STABILIZED (PS) STANDARD RIGHT SIZE 7 PROSTHESIS, KNEE JWH ZIMMER ORTHOPAEDIC MFG. LTD. N/A 62690098

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other