BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39XØ24.5

    MDR report key: 18128714 · Received November 14, 2023

    Report

    Report Number
    3005180920-2023-00868
    Event Type
    Injury
    Date Received
    November 14, 2023
    Date of Event
    October 16, 2023
    Report Date
    November 14, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSD
    UDI-DI
    07630040728072
    PMA / PMN Number
    K193175
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18 OCTOBER 2023: LOT 2240583: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-DEC-2022. EXPIRATION DATE: 2027-11-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL ANALYSIS PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: REVISION AFTER 11 DAYS THAT WAS A RESULT OF A FORMER REVISION RSA. THE FIRST REVISION WAS DUE TO IMPINGEMENT AND THE SECOND ONE IS CAUSED BY DISLOCATION AFTER LIFTING A HEAVY WEIGHT. IT MAY BE POSSIBLE THAT SINCE NOT MUCH TIME HAS PASSED FROM THE FIRST REVISION THE LUXATION MAY BE CAUSED BY INSUFFICIENT RE-ESTABLISHMENT OF SOFT TISSUE TENSION AFTER THE OPERATION. NO FURTHER CONCLUSION CAN BE DRAWN WITH THE ELEMENTS AT HAND. OTHER IMPLANT INVOLVED, BATCH REVIEW PERFORMED ON 18 OCTOBER 2023: REVERSE SHOULDER SYSTEM 04.01.0124 HUMERAL REVERSE HC LINER Ø39/+6MM (K170452) LOT 2241371: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JAN-2023. EXPIRATION DATE: 2027-12-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2022. ON (B)(6) 2023, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED THAT THE PATIENT WAS EXPERIENCING IMPINGEMENT OF THE GLENOSPHERE ON THE SCAPULA WITH SCAPULA NOTCHING. THE CAUSE OF THIS OCCURRENCE IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE, METAPHYSIS, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME REPORTING PAIN DUE TO SHOULDER LUXATION AFTER LIFTING A HEAVY WEIGHT. THE SURGEON REMOVED THE GLENOSPHERE, LINER, METAPHYSIS, GLENOID BASEPLATE AND REPOSITIONED THE BASEPLATE MORE INFERIOR ON THE GLENOID. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1988656 REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39XØ24.5 SHOULDER GLENOSPHERE HSD MEDACTA INTERNATIONAL SA 2240583 07630040728072

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention