BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø32/+0MM

    MDR report key: 16813631 · Received April 26, 2023

    Report

    Report Number
    3005180920-2023-00296
    Event Type
    Injury
    Date Received
    April 26, 2023
    Date of Event
    March 28, 2023
    Report Date
    April 26, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630040706230
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2023. LOT 2008848: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-DEC-2020. EXPIRATION DATE: 2025-NOV-26. 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 INVOLVED IMPLANTS: BATCH REVIEW PERFORMED ON (B)(6) 2023 ON REVERSE SHOULDER SYSTEM 04.01.0178 GLENOSPHERE 32XØ24.5 (K170452) LOT. 183799A LOT 183799A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JAN-2021. EXPIRATION DATE: 2026-JAN-14. 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. BATCH REVIEW PERFORMED ON (B)(6) 2023 ON REVERSE SHOULDER SYSTEM 04.01.0190 THREADED GLENOID BASEPLATE Ø24.5X25 (K171058 ) LOT. 1904748 LOT 1904748: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-NOV-2019. EXPIRATION DATE: 2024-NOV-18. 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. BATCH REVIEW PERFORMED ON (B)(6) 2023 ON REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT. 2003795 LOT 2003795: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-DEC-2020. EXPIRATION DATE: 2025-NOV-26. 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.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. ABOUT 2 YEARS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE PATIENT BY CONVERTING THE REVERSE SHOULDER TO A HEMI-SHOULDER ARTHROPLASTY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791523 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø32/+0MM SHOULDER HUMERAL REVERSE HIGH-CROSS LINER LPH MEDACTA INTERNATIONAL SA 04.01.0116 2008848 07630040706230

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention