BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM 04.01.0163 GLENOID POLYAXIAL LOCKING SCREW - L38

    MDR report key: 18371303 · Received December 21, 2023

    Report

    Report Number
    3005180920-2023-01050
    Event Type
    Injury
    Date Received
    December 21, 2023
    Date of Event
    December 6, 2023
    Report Date
    December 21, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706506
    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 13 DECEMBER 2023 LOT 2315020: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-AUG-2023. EXPIRATION DATE: 2028-07-23. 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: REVERSE SHOULDER SYSTEM 04.01.0159 GLENOID POLYAXIAL LOCKING SCREW - L22 (K170452) LOT 2319630: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-OCT-2023. EXPIRATION DATE: 2028-09-13. 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 04.01.0162 GLENOID POLYAXIAL LOCKING SCREW - L34 (K170452) LOT 2311732: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JUL-2023. EXPIRATION DATE: 2028-06-20. 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 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT 2313417: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-SEPT-2023. EXPIRATION DATE: 2028-09-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 98 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0172 GLENOSPHERE 36XØ27 (K170452) LOT 2317717: 40 ITEMS MANUFACTURED AND RELEASED ON 02-NOV-2023. EXPIRATION DATE: 2028-10-15. 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 04.01.0119 HUMERAL REVERSE HC LINER Ø36/+0MM (K170452) LOT 2308778: 90 ITEMS MANUFACTURED AND RELEASED ON 23-AUG-2023. EXPIRATION DATE: 2028-08-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD PRIMARY SURGERY ON (B)(6) 2023. REVISION SURGERY DUE TO INFECTION WAS PERFORMED ON (B)(6) 2023. GLENOSPHERE AND LINER REVISED SUCCESSFULLY. ON (B)(6) 2023, THE PATIENT UNDERWENT REVISION SURGERY DUE TO INFECTION. THE SURGEON REVISED ALL THE COMPONENTS SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2169232 REVERSE SHOULDER SYSTEM 04.01.0163 GLENOID POLYAXIAL LOCKING SCREW - L38 GLENOID POLYAXIAL LOCKING SCREW PHX MEDACTA INTERNATIONAL SA 2315020 07630040706506

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention