BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIM PRIMARY DCM TIBIAL BEARING 10X79/83MM

    MDR report key: 3160178 · Received June 10, 2013

    Report

    Report Number
    0001825034-2013-01883
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THE REASON FOR THE REVISION PROCEDURE, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 11 STATES, "WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 1999. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2013 DUE TO AN POLY WEAR. THE TIBIAL BEARING AND PATELLAR IMPLANT WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 1999. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2013 DUE TO AN UNKNOWN REASON. THE TIBIAL BEARING AND PATELLAR IMPLANT WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260908 MAXIM PRIMARY DCM TIBIAL BEARING 10X79/83MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 453410

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R