BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39X27

    MDR report key: 11504347 · Received March 17, 2021

    Report

    Report Number
    3005180920-2021-00205
    Event Type
    Injury
    Date Received
    March 17, 2021
    Date of Event
    January 13, 2021
    Report Date
    May 26, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSD
    UDI-DI
    07630040728102
    PMA / PMN Number
    K193175
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE RETURNED ON 26-APR-2021 AND ANALYZED ON 28-APR-2021. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER THE GLENOSPHERE AND ITS LOCKING SCREW DO NOT PRESENT MAJOR SIGNS OF DAMAGE. THE OUTER RIM OF THE LINER IS MILDLY DAMAGED, PROBABLY DUE TO FRICTION WITH THE SCAPULA AFTER THE SHOULDER DISLOCATION. NO ACTION IS SUGGESTED. ALSO, YOU CAN FIND BELOW THE DOCUMENT REVIEW OF THE LINER INVOLVED IN THIS EVENT ADDITIONAL IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0122 HUMERAL REVERSE HC LINER Ø39/+3MM (K170452) LOT. 1910875. BATCH REVIEW PERFORMED ON 15-MAR-2021. LOT: 1910875: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-MAR-2020. EXPIRATION DATE: 18-FEB-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 Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14-MAR-2021: LOT 189946: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-MAY-2019. EXPIRATION DATE: 2024-04-30. 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. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS MANAGER: REVISION SURGERY PERFORMED 1 MONTH AFTER TOTAL SHOULDER ARTHROPLASTY IN A (B)(6) MAN. 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, SUBOPTIMAL IMPLANT POSITION OR INSUFFICIENT RE-ESTABLISHMENT OF SOFT TISSUE TENSION AFTER THE OPERATION. NO FURTHER CONCLUSION CAN BE DRAWN WITH THE ELEMENTS AT HAND.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO RECURRENT SHOULDER LUXATION (GLENOSPHERE FROM THE LINER) 1 MONTH AFTER THE PRIMARY SURGERY. THE PATIENT WAS TREATED, PREVIOUSLY, WITH A CLOSE REDUCTION BUT THE SHOULDER DISLOCATED AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397821 REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39X27 SHOULDER GLENOSPHERE HSD MEDACTA INTERNATIONAL SA 04.01.0211 189946 07630040728102

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention