BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+3MM

    MDR report key: 20154555 · Received September 6, 2024

    Report

    Report Number
    3005180920-2024-00693
    Event Type
    Injury
    Date Received
    September 6, 2024
    Date of Event
    August 9, 2024
    Report Date
    August 11, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706339
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 12-AUG-2024 LOT 2246174: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-APR-2023. EXPIRATION DATE: 2028-03-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANT INVOLVED, BATCH REVIEW PERFORMED ON 12-AUG-2024: REVERSE SHOULDER SYSTEM 04.01.0208 LAT. GLENOSPHERE 39XØ24.5 (K193175) LOT 2243585: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-DEC-2022. EXPIRATION DATE: 2027-11-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 2 OTHER SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW.

    Additional Manufacturer Narrative · 0

    NOTE: THIS INFORMATION WAS DISCOVERED AFTER INVESTIGATION WITH THE BRANCH RELATED TO THE SUBSEQUENT REVISION SURGERY (B)(6). ADDITIONAL IMPLANT INVOLVED (NOT REVISED), BATCH REVIEW PERFORMED ON 11 AUGUST 2025 REVERSE SHOULDER SYSTEM 04.01.0209 LAT. GLENOSPHERE 42XØ24.5 (K193175) LOT 2103993: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-JUL-2021. EXPIRATION DATE: 16-JUN-2026. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CONCLUSIONS: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2023. ON THE (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A JOINT LUXATION. THE SURGEON REVISED THE GLENOSPHERE AND LINER. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A JOINT LUXATION. THE SURGEON REVISED FOR THE SECOND TIME THE GLENOSPHERE AND LINER. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FOR THE GLENOSPHERE. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1864589 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+3MM SHOULDER LINER PHX MEDACTA INTERNATIONAL SA 2246174 07630040706339

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention