BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM 04.01.0208 LAT. GLENOSPHERE 39XØ24.5

    MDR report key: 14286985 · Received May 5, 2022

    Report

    Report Number
    3005180920-2022-00326
    Event Type
    Injury
    Date Received
    May 5, 2022
    Date of Event
    April 5, 2022
    Report Date
    July 15, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSD
    UDI-DI
    07630040728072
    PMA / PMN Number
    K193175
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29-APR-2022. LOT 2005601A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JAN-2021. EXPIRATION DATE: 2026-01-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ONE YEAR AFTER RSA, AT A FOLLOW UP VISIT THE GLENOSPHERE IS FOUND ROTATED VERSUS THE INITIAL POSITION. FROM THE RADIOGRAPH SUPPLIED, IT APPEARS THAT IT MAY ALSO HAVE DETACHED IN PART FROM THE TAPER SPIGOT OF THE BASEPLATE. THIS MAY BE DUE TO INCOMPLETE SEATING OF THE BASEPLATE FIXATION SCREWS, TO A QUASI-TRAUMATIC EVENT, OR TO ANOTHER FACTOR THAT WE CANNOT TRACE WITH THE INFORMATION AT HAND. RE-POSITIONING OF THE GLENOSPHERE IS HIGHLY RECOMMENDABLE IF THE PATIENT CONDITIONS ALLOW. OTHER DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 29-APR-2022. REVERSE SHOULDER SYSTEM 04.01.0191 THREADED GLENOID BASEPLATE Ø24.5X30 (K171058) LOT 1904749: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-DEC-2019. EXPIRATION DATE: 2024-11-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    CORRECTION: AFTER DIFFERENT E-MAILS ON 08.07.2022 WE CONCLUDED THAT DUE TO A MISUNDERSTANDING THE ALL DETAILS, EVENT DESCRIPTION INCLUDED ARE WRONG. THE PATIENT HAD NOTHING WRONG, IT WAS NOT REVISED AND HAD NOT ANY ADVERSE EVENT. ALL COMPONENTS ARE MANAGED AS ASSOCIATED ITEMS.

    Description of Event or Problem · 0

    THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IT WAS REVEALED THAT THE GLENOSPHERE ECCENTRICITY HAS SHIFTED SUPERIORLY. THE SURGEON PLANS TO REVISE THE PATIENT ON (B)(6) 2022. PRIMARY SURGERY WAS PERFORMED IN (B)(6) 2021.

    Description of Event or Problem · 0

    THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IT WAS REVEALED THAT THE GLENOSPHERE ECCENTRICITY HAS SHIFTED SUPERIORLY. AFTER DIFFERENT E-MAILS ON 08.07.2022 WE CONCLUDED THAT DUE TO A MISUNDERSTANDING THE ALL DETAILS, EVENT DESCRIPTION INCLUDED ARE WRONG. THE PATIENT HAD NOTHING WRONG, IT WAS NOT REVISED AND HAD NOT ANY ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1569154 REVERSE SHOULDER SYSTEM 04.01.0208 LAT. GLENOSPHERE 39XØ24.5 SHOULDER GLENOSPHERE HSD MEDACTA INTERNATIONAL SA 04.01.0208 2005601A 07630040728072

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention