BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOSPHERE 36X27

    MDR report key: 12067299 · Received June 25, 2021

    Report

    Report Number
    3005180920-2021-00521
    Event Type
    Injury
    Date Received
    June 25, 2021
    Date of Event
    May 27, 2021
    Report Date
    June 25, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706599
    PMA / PMN Number
    K170452
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 24 JUNE 2021: LOT 2003845A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-JAN-2021. EXPIRATION DATE: 2025-12-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. PRELIMINARY INVESTIGATION PERFORMED BY R&D DEPARTMENT: THE FRACTURE OF THE ACROMION IS KNOWN TO BE ASSOCIATED TO REPETITIVE ABUTMENT OF THE HUMERUS OR OVERTENSIONING OF THE DELTOID CAUSED BY EXCESSIVE HUMERAL DISTALIZATION. GIVEN THE INFORMATION AT HAND AND THE ABSENCE OF X-RAYS, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT. NO ACTION IS SUGGESTED. ANOTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 24 JUNE 2021: REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT. 2003795:(B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-DEC-2020. EXPIRATION DATE: 2025-11-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0120 HUMERAL REVERSE HC LINER Ø36/+3MM (K170452) LOT 179117: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-APR-2018. EXPIRATION DATE: 2023-04-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0184 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 11 (K180089) LOT 1900960: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-APR-2019. EXPIRATION DATE: 2024-04-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    PRIMARY SURGERY PERFORMED IN (B)(6) 2021. FRACTURE OF THE ACROMION DETECTED 1 MONTH AFTER THE SURGERY. NO REVISION SURGERY SCHEDULED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961189 REVERSE SHOULDER SYSTEM GLENOSPHERE 36X27 GLENOSPHERE PHX MEDACTA INTERNATIONAL SA 04.01.0172 2003845A 07630040706599

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other