BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 36/+6MM

    MDR report key: 11116243 · Received January 5, 2021

    Report

    Report Number
    3005180920-2021-00008
    Event Type
    Injury
    Date Received
    January 5, 2021
    Date of Event
    December 8, 2020
    Report Date
    February 26, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706285
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICES RETURNED ON 27-JAN-2021 AND ANALYZED. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER. THE VISUAL INSPECTION WAS PERFORMED ON WEDNESDAY, 27TH JANUARY 2021. THE ARTICULAR SURFACE OF THE LINER HAS SCRACTCHES, PROBABLY CAUSED DURING THE REMOVAL OF THE IMPLANT. THE ARTICULAR SUFACE OF THE GLENOSPHERE IS PARTIALLY DULL, PROBABLY DUE TO CONTACT WITH THE REVERSE METAPHYSIS. THE GLENOSPHERE SCREW IS PARTIALLY DISCOLOURED DUE TO FRICTION WITH THE INNER RECESS GLENOSPHERE. THE EXPLANTS INCLUDED THE "REVERSE METAPHYSIS SCREW".

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 28-DEC-2020: LOT 2000923: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-MAY-2020. EXPIRATION DATE: 19-APR-2025. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 28-DEC-2020: REVERSE SHOULDER SYSTEM 04.01.0207 LAT. GLENOSPHERE 36XØ24.5 (K193175)LOT. 2003791 : LOT 2003791: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-SEP-2020. EXPIRATION DATE: 02-SEP-2025. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED ON (B)(6) 2020 DUE TO RECURRENT SHOULDER DISLOCATION (GLENOSPHERE AND INLAY HAVE BEEN REVISED) 3 MONTHS AFTER THE PRIMARY SURGERY((B)(6) 2020). THE PATIENT WAS ALREADY REVISED, AT THE BEGINNING OF (B)(6) 2020, WHERE THE INLAY HAS BEEN CHANGED FROM Ø36/+0MM TO Ø36/+6MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17056 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 36/+6MM REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER PHX MEDACTA INTERNATIONAL SA 04.01.0121 2000923 07630040706285

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention