BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ27

    MDR report key: 7897538 · Received September 21, 2018

    Report

    Report Number
    3005180920-2018-00718
    Event Type
    Injury
    Date Received
    September 21, 2018
    Date of Event
    August 24, 2018
    Report Date
    October 31, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706605
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D SHOULDER MANAGER ON OCTOBER 23, 2018: THE GLENOSPHERE SHOWS SIGNS ON THE ARTICULAR SURFACE, PRESUMABLY CAUSED BY THE FRICTION WITH THE REVERSE METAPHYSIS AFTER THE DISLOCATION. THE REVERSE LINER SHOWS DAMAGE ON THE OUTER BORDER AND THE ARTICULAR SURFACE, PRESUMABLY LED DURING THE IMPLANT REMOVAL DURING THE REVISION SURGERY. NO IMPLANT-RELATED ROOT CAUSE CAN BE IDENTIFIED FOLLOWING THE INSPECTION. THE DISLOCATION MAY HAVE OCCURRED DUE TO INSTABILITY-RELATED FACTORS (TENSIONING, HINGE-OPEN PHENOMENON, ..).

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 SEPTEMBER 2018; LOT 174736: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 OCOTBER 2017. EXPIRATION DATE: 27.09.2022. 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. ADDITIONAL IMPLANT REVISED: REVERSE SHOULDER SYSTEM 04.01.0122 HUMERAL REVERSE HC LINER Ø39/+0MM (K170452), LOT 175047: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 SEPTEMBER 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER ON SEP 14, 2018: RECURRENT DISLOCATION FEW WEEKS AFTER PRIMARY REVERSE SHOULDER ARTHROPLASTY IN A (B)(6) YEAR OLD MAN. DISLOCATIONS ARE POSSIBLE, LITERATURE DESCRIBED ADVERSE EVENTS AFTER REVERSE SHOULDER PROCEDURES AND ARE MAINLY DUE TO INSUFFICIENT SOFT TISSUE TENSION. IT IS THEREFORE COMMON PRACTICE TO RESORT TO A THICKER POLYETHYLENE LINER AND A BIGGER GLENOID COMPONENT TO RESTORE JOINT TENSION. THERE IS NO REASON TO SUSPECT A FAULTY DEVICE.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO SHOULDER LUXATION ABOUT 2 MONTHS AFTER PRIMARY. INLAY AND GLENOSPHERE WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740765 REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ27 SHOULDER METAL GLENOSPHERE PHX MEDACTA INTERNATIONAL SA 04.01.0173 174736 07630040706605

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention