BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM STD HUMERAL DIAPHYSIS - CEMENTLESS - 11

    MDR report key: 7552096 · Received May 30, 2018

    Report

    Report Number
    3005180920-2018-00385
    Event Type
    Injury
    Date Received
    May 30, 2018
    Date of Event
    April 30, 2018
    Report Date
    May 30, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706056
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 28 MAY 2018; LOT 172245: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31 AUGUST 2017. EXPIRATION DATE: 2022-07-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +9MM/0° REFERENCE 04.01.0111 (K170452); LOT 174655: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 OCTOBER 2017. EXPIRATION DATE: 2022-09-11; NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM REFERENCE 04.01.0122 (K170452); LOT 173418: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 JULY 2017. EXPIRATION DATE: 2022-06-18 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN 18 DAYS AFTER PRIMARY. THE SURGEON DETERMINED THAT THE PATIENT HAD DISLOCATED. THE CAUSE OF DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE DIAPHYSIS, METAPHYSIS, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395500 REVERSE SHOULDER SYSTEM STD HUMERAL DIAPHYSIS - CEMENTLESS - 11 HUMERAL DIAPHYSIS CEMENTLESS PHX MEDACTA INTERNATIONAL SA 172245 07630040706056

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention