BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISC HUM 4X100MM RT FLANGED C

    MDR report key: 2700805 · Received August 15, 2012

    Report

    Report Number
    0001825034-2012-01296
    Event Type
    Injury
    Date Received
    August 15, 2012
    Date of Event
    June 22, 2012
    Report Date
    July 18, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDC
    PMA / PMN Number
    PK013042
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY WAS NOTIFIED OF THE EVENT. SHOULD THE USER FACILITY SUBMIT A MEDWATCH REPORT OR ADDITIONAL INFORMATION, BIOMET WILL FORWARD A SUPPLEMENTAL REPORT TO THE FDA. 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 RELATED DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01286, 01295 & 01296).

    Additional Manufacturer Narrative · 1

    USER FACILITY FORWARDED A REPORT AFTER RECEIVING A FAXED LETTER FROM BIOMET ON (B)(4) 2012 WITH EVENT DETAILS. THIS FOLLOW-UP CORRESPONDS TO THE SAME EVENT MENTIONED IN MEDWATCH FORM 1306898960-2012-4, WHICH IS ATTACHED. THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01286-2, 01295-1 & 01296-1).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL ELBOW ARTHROPLASTY (B)(6) 2010. A SUBSEQUENT REVISION WAS PERFORMED (B)(6) 2012 DUE TO INFECTION. TRICEP RUPTURE WAS REPAIRED AND ALL IMPLANTS WERE REMOVED AND REPLACED WITH CEMENT SPACER MOLD.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL ELBOW ARTHROPLASTY (B)(6) 2010. A SUBSEQUENT REVISION WAS PERFORMED (B)(6) 2012 DUE TO INFECTION. TRICEP RUPTURE WAS REPAIRED AND ALL IMPLANTS WERE REMOVED AND REPLACED WITH CEMENT SPACER MOLD. TO DATE, PROCEDURE TO REIMPLANT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISC HUM 4X100MM RT FLANGED C PROSTHESIS, ELBOW JDC BIOMET ORTHOPEDICS N/A 027650

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R