BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 19042188 · Received April 4, 2024

    Report

    Report Number
    3005180920-2024-00182
    Event Type
    Injury
    Date Received
    April 4, 2024
    Date of Event
    March 8, 2024
    Report Date
    April 4, 2024
    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 14 MARCH 2024 LOT 2318843A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-DEC-2023. EXPIRATION DATE: 2028-11-16. 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. OTHER DEVICES INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 14 MARCH 2024. REVERSE SHOULDER SYSTEM 04.01.0120 HUMERAL REVERSE HC LINER Ø36/+3MM (K170452) LOT. 2305694 LOT 2305694: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-AUG-2023. EXPIRATION DATE: 2028-07-17. 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. REVERSE SHOULDER SYSTEM 04.01.0157 GLENOID POLYAXIAL LOCKING SCREW - L14 (K170452) LOT. 2116353A LOT 2116353A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-FEB-2022. EXPIRATION DATE: 2027-01-24. 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. REVERSE SHOULDER SYSTEM 04.01.0157 GLENOID POLYAXIAL LOCKING SCREW - L14 (K170452) LOT. 2240564 LOT 2240564: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-NOV-2022. EXPIRATION DATE: 2027-11-09. 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. REVERSE SHOULDER SYSTEM 04.01.0157 GLENOID POLYAXIAL LOCKING SCREW - L14 (K170452) LOT. 2335881 LOT 2335881: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-OCT-2023. EXPIRATION DATE: 2028-09-30. 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. REVERSE SHOULDER SYSTEM 04.01.0182 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 9 (K180089) LOT. 2244678 LOT 2244678: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JAN-2023. EXPIRATION DATE: 2028-01-03. 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. REVERSE SHOULDER SYSTEM 04.01.0207 LAT. GLENOSPHERE 36XØ24.5 (K193175) LOT. 2307390 LOT 2307390: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-MAY-2023. EXPIRATION DATE: 2028-05-03. 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. REVERSE SHOULDER SYSTEM 04.01.0401 GRS BASEPLATE - Ø24.5X20 - FULL WEDGE 15° (K231911) LOT. 2307089 LOT 2307089: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-NOV-2023. EXPIRATION DATE: 2028-11-04. 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

    AT ABOUT 3 WEEKS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND 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
    2334182 REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0° HUMERAL REVERSE METAPHYSIS PHX MEDACTA INTERNATIONAL SA 2318843A 07630040706179

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention