BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARGE LT 32MM ID CONST SCAPULA

    MDR report key: 3792065 · Received May 6, 2014

    Report

    Report Number
    0001825034-2014-03602
    Event Type
    Injury
    Date Received
    May 6, 2014
    Report Date
    April 8, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PCUSTOMIZED
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 OR DEVIATION. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 3 STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." THIS REPORT IS NUMBER 2 OF 5 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03601 / 03605).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A SHOULDER ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, A REVISION PROCEDURE IS INDICATED DUE TO INFECTION. THERE HAS BEEN NO REPORTED REVISION TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270479 LARGE LT 32MM ID CONST SCAPULA PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 377590

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R