BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR ECCENTR. GLENOSPHERE

    MDR report key: 8358179 · Received February 21, 2019

    Report

    Report Number
    3008021110-2019-00011
    Event Type
    Injury
    Date Received
    February 21, 2019
    Date of Event
    January 8, 2019
    Report Date
    February 20, 2019
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    PHX
    PMA / PMN Number
    K142139
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHRS OF THE INVOLVED LOTS # (1810512, 17AT060), NO PREEXISTING ANOMALY WAS FOUND. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    REVISION SURGERY OCCURRED ON (B)(6) 2019 DUE TO SHOULDER DISLOCATION. PRIMARY REVERSE ARTHROPLASTY WAS ORIGINALLY PERFORMED ON (B)(6) 2018. ACCORDING TO INFO PROVIDED, PATIENT HAD RECENTLY FALLEN BUT IT WAS BELIEVED THAT DUE TO PRESENCE OF POLY WEAR, PATIENT HAD BEEN DISLOCATED FOR A WHILE. A CLOSED REDUCTION WAS ATTEMPTED BEFORE REVISION SURGERY, BUT SINCE STABILITY COULD NOT BE ACHIEVED, PATIENT WAS THEN REVISED FROM +3MM RETENTIVE POLY (CODE# 1365.50.816, LOT# 17AT060) TO A +9MM EXTENSION AND A STD RETENTIVE POLY GLENOSPHERE WAS REPLACED WITH A SAME SIZE (DIA. 40MM) ECCENTRIC GLENOSPHERE (CODE# 1376.09.040, LOT# 1810512), AND POSITIONED APPROPRIATELY FOR STABILITY. EVENT HAPPENED IN UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150088 SMR ECCENTR. GLENOSPHERE SMR ECCENTR. GLENOSPHERE (PHX KWS) PHX LIMACORPORATE SPA 1376.09.040 1810512

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention