BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 44-36 STD +3 HMRL BRG

    MDR report key: 5110165 · Received September 29, 2015

    Report

    Report Number
    0001825034-2015-04095
    Event Type
    Injury
    Date Received
    September 29, 2015
    Date of Event
    September 10, 2015
    Report Date
    September 10, 2015
    Manufacturer
    BIOMET SET
    Product Code
    PAO
    PMA / PMN Number
    PK113121
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 9 STATES, ¿DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY OR EXCESSIVE ACTIVITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS.¿ THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 0001825034-2015-04094 / 04095).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2015. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2015 DUE TO DISLOCATION. THE DISLOCATION WAS DUE TO LENGTHENING OF THE DELTOID AND SOFT TISSUE TENSION. THE SURGEON REVISED THE STEM, TRAY, BEARING, AND GLENOSPHERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641576 E1 44-36 STD +3 HMRL BRG PROSTHESIS, SHOULDER PAO BIOMET SET N/A 492430

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R