BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN ALL POLY PATELLA SIZE 32 MM DIA. STANDARD 8.5 MM THICKNESS

    MDR report key: 6267900 · Received January 20, 2017

    Report

    Report Number
    0002648920-2017-00032
    Event Type
    Injury
    Date Received
    January 20, 2017
    Date of Event
    December 20, 2016
    Report Date
    November 3, 2017
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    PMA / PMN Number
    PK933785
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: NEXGEN LPS - MOBILE ARTICULAR SURFACE CATALOG#5946-070-10, LOT# 61529730, NEXGEN LPS-FLEX FEMORAL COMPONENT, CATALOG#00-5962-017-51 LOT# 61292221, NEXGEN FLUTED STEM MOBILE TIBIAL COMPONENT CATALOG# 5946-70-01, LOT# 615081151. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH SINCE THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND, IF WARRANTED, FURTHER MEDWATCH REPORTS WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    FOREIGN - (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. 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 · 1

    IT WAS REPORTED PATIENT WAS REVISED DUE TO PATELLAR PAIN AND WEAR APPROXIMATELY 6 YEARS POST IMPLANTATION. THE PATELLA AND BEARING WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50465 NEXGEN ALL POLY PATELLA SIZE 32 MM DIA. STANDARD 8.5 MM THICKNESS PROSTHESIS, KNEE JWH ZIMMER MANUFACTURING B.V. N/A 61459824

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R