BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVS TRAY CO 44MM

    MDR report key: 3800888 · Received May 8, 2014

    Report

    Report Number
    0001825034-2014-03720
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 10, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK113069
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCES. DIMENSIONAL EVALUATION FOUND COMPONENT TO BE WITHIN APPROPRIATE DESIGN SPECIFICATION WITH EXCEPTION OF DEFORMATION DUE TO ASSEMBLY ISSUES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2014. DURING THE PROCEDURE, THE HUMERAL BEARING AND HUMERAL TRAY WOULD NOT ENGAGE. ANOTHER HUMERAL TRAY AND BEARING WERE AVAILABLE TO COMPLETE THE PROCEDURE; HOWEVER, A FIFTY MINUTE DELAY OCCURRED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277703 COMP RVS TRAY CO 44MM PROSTHESIS, KNEE KWS BIOMET ORTHOPEDICS N/A 503330

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R