BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAESTRO CARP PLATE 9X37 AUG 12

    MDR report key: 5499268 · Received March 14, 2016

    Report

    Report Number
    0001825034-2016-00868
    Event Type
    Injury
    Date Received
    March 14, 2016
    Date of Event
    December 4, 2015
    Report Date
    February 15, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWJ
    PMA / PMN Number
    PK042032
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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 OR DEVIATION. EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DIMENSIONAL EVALUATION COULD NOT BE COMPLETED DUE TO DAMAGE AND BONE ONGROWTH ATTACHED TO THE POROUS COATED SURFACES. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 5 STATES, ¿LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, AND/OR EXCESSIVE ACTIVITY.¿ NUMBER 12 STATES, "WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES." THIS REPORT IS NUMBER 2 OF 2 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2015-05092-3 / 2016-00868).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A WRIST PROCEDURE ON (B)(6) 2010. SUBSEQUENTLY, PATIENT UNDERWENT A SYNOVECTOMY ON (B)(6) 2013 DUE TO PAIN. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2015 DUE TO LOOSENING. DURING THE PROCEDURE METALLOSIS WAS NOTED. ALL COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155221 MAESTRO CARP PLATE 9X37 AUG 12 PROSTHESIS, WRIST JWJ BIOMET ORTHOPEDICS N/A 749970

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R