BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVS HMRL TI TRAY 44MM

    MDR report key: 4375990 · Received December 31, 2014

    Report

    Report Number
    0001825034-2014-09301
    Event Type
    Injury
    Date Received
    December 31, 2014
    Date of Event
    December 8, 2014
    Report Date
    March 6, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    PAO
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: ¿FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT.¿D6 - IMPLANT DATE: UNKNOWNE1 - INITIAL REPORTER PHONE: (416)603-2581

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DURING THE EVALUATION, IT WAS NOTED THE ROOT CAUSE OF THE EVENT WAS MOST LIKELY DUE TO PATIENT CONDITION BY OVERSTRESSING THE JOINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A COMPREHENSIVE REVERSE TOTAL SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2014 DUE TO THE MALE TAPER FRACTURING OFF THE HUMERAL TRAY AND GETTING STUCK IN THE STEM. THERE WAS A 90 MINUTE DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861276 COMP RVS HMRL TI TRAY 44MM PROSTHESIS, SHOULDER PAO BIOMET ORTHOPEDICS N/A 593410

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R