BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL COMPONENT PRECOAT SIZE E MINUS (E-) LEFT

    MDR report key: 15294688 · Received August 25, 2022

    Report

    Report Number
    3007963827-2022-00214
    Event Type
    Malfunction
    Date Received
    August 25, 2022
    Report Date
    September 21, 2022
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    JWH
    UDI-DI
    00889024191211
    PMA / PMN Number
    K173057
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). IMPLANT DATE: (B)(6) 2020. MEDICAL PRODUCT: CR ART SURF CH34/YELLOW 10MM CATALOG # 90597003010 LOT # 64519443. ALL POLY PETELLA STANDARD CEMENTED SIZE 32 MM DIAMETER 8.5 MM THICKNESS CATALOG # 00597206532 LOT # 64440565. ST PRC TIB PLT SIZE 3 CATALOG # 00-5980-037-01 LOT # J6648248. SUGGESTED COMPONENT CODE: MECHANICAL G4-FEMUR. MULTIPLE MDR REPORTS FILLED FOR THIS EVENT: 0001822565-2022-02317. THIS PRODUCT WAS INITIALLY REPORTED UNDER 0001822565-2022-02318. 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. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. UPDATED: B4, B5, G3, G6, H1, H2 CORRECTION: B1, B2, H1.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT IS EXPERIENCING RANGE OF MOTION AND STIFFNESS ISSUE IN KNEE POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2102018 FEMORAL COMPONENT PRECOAT SIZE E MINUS (E-) LEFT PROSTHESIS KNEE JWH ZIMMER ORTHOPAEDIC MFG. LTD. N/A 63241938 00889024191211

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other