BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAESTRO RAD W/BRG 7X15 9.0 LT

    MDR report key: 5308243 · Received December 17, 2015

    Report

    Report Number
    0001825034-2015-05092
    Event Type
    Injury
    Date Received
    December 17, 2015
    Date of Event
    December 4, 2015
    Report Date
    February 15, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KTT
    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. DEVICE AVAILABILITY - THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED BY BIOMET ORTHOPEDICS TO DATE. IN THE EVENT THAT THE DEVICE IS RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA TO PROVIDE RESULTS. 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." THE SYNOVECTOMY PROCEDURE HAS PREVIOUSLY BEEN REPORTED (B)(4).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2015-05092-3 / 2016-00868).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. 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.

    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. THE RADIAL COMPONENT WAS REMOVED AND REPLACED.

    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
    834031 MAESTRO RAD W/BRG 7X15 9.0 LT PROSTHESIS, WRIST KTT BIOMET ORTHOPEDICS N/A 516830

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R