BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X25

    MDR report key: 19565507 · Received June 19, 2024

    Report

    Report Number
    3005180920-2024-00412
    Event Type
    Injury
    Date Received
    June 19, 2024
    Date of Event
    May 22, 2024
    Report Date
    June 19, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706421
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 23 MAY 2024. LOT 2010663: 129 ITEMS MANUFACTURED AND RELEASED ON 12-FEB-2021. EXPIRATION DATE: 2026-JAN-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 127 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINCAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT LATE INFECTION IN RSA, 2 YEARS AND 8 MONTHS AFTER PRIMARY OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING RSA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES. ADDITIONAL INVOLVED IMPLANTS. BATCH REVIEW PERFORMED ON 23 MAY 2024 ON REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT. 2003981 LOT 2003981: 193 ITEMS MANUFACTURED AND RELEASED ON 06-MAY-2021. EXPIRATION DATE: 2026-APR-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 178 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 1 SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 23 MAY 2024 ON REVERSE SHOULDER SYSTEM 04.01.0161 GLENOID POLYAXIAL LOCKING SCREW - L30 (K170452) LOT. 2010933 LOT 2010933: 190 ITEMS MANUFACTURED AND RELEASED ON 23-DEC-2020. EXPIRATION DATE: 2025-DEC-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 179 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 23 MAY 2024 ON REVERSE SHOULDER SYSTEM 04.01.0163 GLENOID POLYAXIAL LOCKING SCREW - L38 (K170452) LOT. 1909892 LOT 1909892: 50 ITEMS MANUFACTURED AND RELEASED ON 24-MAR-2020. EXPIRATION DATE: 2025-MAR-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 47 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 23 MAY 2024 ON REVERSE SHOULDER SYSTEM 04.01.0020 STD HUMERAL DIAPHYSIS - CEMENTED - 14 (K170452) LOT. 2110749 LOT 2110749: 8 ITEMS MANUFACTURED AND RELEASED ON 07-SEP-2021. EXPIRATION DATE: 2026-JUL-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ONLY THIS ITEM OF THIS LOT HAS BEEN SOLD. BATCH REVIEW PERFORMED ON 23 MAY 2024 ON REVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE 39XØ27 (K170452) LOT. 2003974 LOT 2003974: 66 ITEMS MANUFACTURED AND RELEASED ON 25-FEB-2021. EXPIRATION DATE: 2026-FEB-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 1 SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 23 MAY 2024 ON MECTAPLUG 01.33.101 MECTAPLUG PE SIZE 1 () LOT. 2106019 LOT 2106019: 214 ITEMS MANUFACTURED AND RELEASED ON 12-JUL-2021. EXPIRATION DATE: 2026-JUN-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 213 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. THE DEVICE IS NOT MARKETED IN US.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED ABOUT 2 YEARS AND 8 MONTHS AFTER THE PRIMARY SURGERY DUE TO INFECTION (PROPIONI-BACTERIUM). ALL COMPONENTS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596085 REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X25 SHOULDER REVERSE SYSTEM GLENOID BASEPLATE PHX MEDACTA INTERNATIONAL SA 2010663 07630040706421

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention