BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 20451675 · Received October 15, 2024

    Report

    Report Number
    3005180920-2024-00854
    Event Type
    Injury
    Date Received
    October 15, 2024
    Date of Event
    September 20, 2024
    Report Date
    October 15, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706179
    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 02-OCT-2024. LOT 2317074A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-JAN-2024. EXPIRATION DATE: 2028-12-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 115 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: EARLY INFECTION IN RSA, 7 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. ADDIITONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 02 OCT 2024: REVERSE SHOULDER SYSTEM 04.01.0002 STD HUMERAL DIAPHYSIS - CEMENTLESS - 7 (K170910) LOT. 2113349. LOT 2113349: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-NOV-2021. EXPIRATION DATE: 2026-10-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 11 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0160 GLENOID POLYAXIAL LOCKING SCREW - L26 (K170452) LOT. 2347369 LOT 2347369: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-FEB-2024. EXPIRATION DATE: 2029-01-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 86 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0159 GLENOID POLYAXIAL LOCKING SCREW - L22 (K170452) LOT. 2340120. LOT 2340120: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-DEC-2023. EXPIRATION DATE: YYYY-MM-DD. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 44 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0169 GLENOSPHERE - Ø36X24.5 (K170452) LOT. 2335891. LOT 2335891: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-JAN-2024. EXPIRATION DATE: 2028-12-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 62 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0119 HUMERAL REVERSE HC LINER Ø36/+0MM (K170452) LOT. 2342004. LOT 2342004: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-DEC-2023. EXPIRATION DATE: 2028-12-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 89 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0301 GRS BASEPLATE - Ø24.5X20 +3MM (K213459) LOT. 2314208 LOT 2314208: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-NOV-2023. EXPIRATION DATE: 2028-11-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 24 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 7 MONTHS AFTER PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF STAPHYLOCOCCUS EPIDERMIDIS INFECTION. THE SURGEON EXPLANTED ALL THE COMPONENTS AND IMPLANTED A CEMENT SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87276 SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS PHX MEDACTA INTERNATIONAL SA 04.01.0110 2317074A 07630040706179

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention