BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIM FMRL AUGMENT BLOCK

    MDR report key: 1052311 · Received May 21, 2008

    Report

    Report Number
    1825034-2008-00153
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 14, 2008
    Manufacturer
    BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K915132
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL OF RETURNED DEVICE FOUND IMPLANT DID NOT MEET DESIGN SPECS. IN RESPONSE TO RECENT FDA AUDIT, RETROSPECTIVE REVIEW WAS PERFORMED, EVENT WAS REASSESSED AND DETERMINED TO MEET REPORTING REQUIREMENTS AS DEVICE MALFUNCTION. CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN INITIATED. THIS REPORT FILED ON MAY 21, 2008.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE PRODUCT FROM THIS LOT HAS BEEN ACCOUNTED FOR. INVESTIGATION DETERMINED LOT WAS MANUFACTURED IN JULY 2000. SUBSEQUENT TO THE MANUFACTURE OF THIS LOT, ACTIONS HAVE BEEN INITIATED IN AN EFFORT TO PREVENT LABELING ERRORS WHICH INCLUDE: LABEL PRINTING PROCESS CHANGED TO ONLY ALLOW ONE PRINTING OF LABELS. ADDITIONAL PRINTING REQUIRES ESCALATION TO SUPERVISOR; WALK-THRU AUDITS ARE PERFORMED BY THE SUPERVISORS; ADDITIONAL TRAINING ON INTERNAL PROCEDURES; INSPECTION CRITERIA AND PROCESS SPECIFICATIONS WERE REVIEWED AND UPDATED AS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING KNEE PROCEDURE IN 2008, WHEN PACKAGE LABELED 145374 LOT 958630 WAS OPENED, ITEM IN PACKAGE WAS MARKED 145325 LOT 958330.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING KNEE PROCEDURE IN 2008, WHEN PACKAGE LABELED 145374 LOT 958630 WAS OPENED, ITEM IN PACKAGE WAS MARKED 145325 LOT 958330.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIM FMRL AUGMENT BLOCK PROSTHESIS, KNEE COMPONENT JWH BIOMET, INC. NA 958630

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK