BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0°

    MDR report key: 17395199 · Received July 26, 2023

    Report

    Report Number
    3005180920-2023-00580
    Event Type
    Injury
    Date Received
    July 26, 2023
    Date of Event
    July 5, 2023
    Report Date
    July 26, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706179
    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 (B)(6) 2023: LOT 2004008: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAY-2021. EXPIRATION DATE: 2026-04-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS INVOLVED: BATCH REVIEW PERFORMED ON (B)(6) 2023 ON REVERSE SHOULDER SYSTEM 04.01.0120 HUMERAL REVERSE HC LINER Ø36/+3MM (K170452) LOT. 2103236 LOT 2103236: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-MAY-2021. EXPIRATION DATE: 2026-05-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON (B)(6) 2023 ON REVERSE SHOULDER SYSTEM 04.01.0159 GLENOID POLYAXIAL LOCKING SCREW - L22 (K170452) LOT. 2103780 LOT 2103780: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JUNE-2021. EXPIRATION DATE: 2026-05-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON (B)(6) 2023 ON REVERSE SHOULDER SYSTEM 04.01.0161 GLENOID POLYAXIAL LOCKING SCREW - L30 (K170452) LOT. 2106855 LOT 2106855: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JULY-2021. EXPIRATION DATE: 2026-06-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON (B)(6) 2023 ON REVERSE SHOULDER SYSTEM 04.01.0181 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 8 (K180089) LOT. 2005424 LOT 2005424: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-SEP-2020. EXPIRATION DATE: 2025-09-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN 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. 2106782 LOT 2106782: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-SEP-2021. EXPIRATION DATE: 2026-08-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON (B)(6) 2023 ON REVERSE SHOULDER SYSTEM 04.01.0207 LAT. GLENOSPHERE 36XØ24.5 (K193175) LOT. 2009001 LOT 2009001: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-APR-2021. EXPIRATION DATE: 2026-04-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY AT 1 YEAR AND 5 MONTHS POST PRIMARY DUE TO INFECTION, THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604869 REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0° SHOULDER HUMERAL REVERSE SYSTEM METAPHYSIS PHX MEDACTA INTERNATIONAL SA 2004008 07630040706179

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention