BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 36/+0MM

    MDR report key: 12526084 · Received September 24, 2021

    Report

    Report Number
    3005180920-2021-00765
    Event Type
    Injury
    Date Received
    September 24, 2021
    Date of Event
    August 26, 2021
    Report Date
    September 24, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706261
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 27 AUGUST 2021: LOT 2009951: (B)(4) ITEMS MANUFACTURED AND RELEASED ON29-JAN-2021. EXPIRATION DATE: 2026-JAN-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANOTHER SIMILAR REPORTED EVENT [(B)(4)]. CLINICAL EVALUATION PERFORMED BA MEDACTA MEDICAL AFFAIRS DEPARTMENT: SHOULDER DISLOCATION OCCURRED FEW DAYS AFTER PRIMARY REVERSE SHOULDER ARTHROPLASTY.THE COMPONENTS REMAINED INTACT AND WE CANNOT DETECT ANY HINT OF A DEFECT THAT LED TO THE PROBLEM. THESE EVENTS ARE NORMAL ORIGINATED BY PROGRESSION OF DISEASE TO THE SOFT TISSUES OR INSUFFICIENT RE-ESTABLISHMENT OF SOFT TISSUE TENSION AFTER THE OPERATION. NO FURTHER CONCLUSION CAN BE DRAWN WITH THE ELEMENTS AT HAND. ANOTHER DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 27 AUGUST 2021: REVERSE SHOULDER SYSTEM 04.01.0278 SENSITIN LAT. GLENOSPHERE 36XØ24.5 (K203755) LOT 2012762: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-MARCH-2021. EXPIRATION DATE: 2026-MARCH-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.

    Description of Event or Problem · 1

    REVISION SURGERY 3 DAYS AFTER THE PRIMARY SURGERY DUE TO THE DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE SURGEON BELIEVES THE CAUSE WAS THE PRESENCE OF A HEMATOMA AND THE PATIENT'S OBESITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1424653 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 36/+0MM HUMERAL REVERSE LINER PHX MEDACTA INTERNATIONAL SA 04.01.0119 2009951 07630040706261

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention