BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM 04.01.0127 HUMERAL REVERSE HC LINER Ø42/+6MM

    MDR report key: 15869298 · Received November 28, 2022

    Report

    Report Number
    3005180920-2022-00900
    Event Type
    Injury
    Date Received
    November 28, 2022
    Date of Event
    November 7, 2022
    Report Date
    November 28, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706346
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 10 NOVEMBER 2022: LOT 179122: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAR-2018. EXPIRATION DATE: 2023-MAR-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. OTHER DEVICES INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0212 LAT. GLENOSPHERE 42XØ27 (K193175) LOT 2103690: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-AUG-2018. EXPIRATION DATE: 2023-AUG-21. 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 2003392: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-DEC-2020. EXPIRATION DATE: 2025-NOV-19. 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 04.01.0009 STANDARD HUMERAL DIAPHYSIS - CEMENTLESS - 14 (K170452) LOT 176942: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-NOV-2017. EXPIRATION DATE: 2022-OCT-26. 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 1905798: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-AUG-2019. EXPIRATION DATE: 2024-JUL-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 04.01.0161 GLENOID POLYAXIAL LOCKING SCREW - L30 (K170452) LOT 2005667: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-AUG-2020. EXPIRATION DATE: 2025-JUL-22. 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 04.01.0158 GLENOID POLYAXIAL LOCKING SCREW - L18 (K170452) LOT 2010015: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-NOV-2020. EXPIRATION DATE: 2025-NOV-12. 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 184570: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-DEC-2018. EXPIRATION DATE: 2023-DEC-05. 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 04.01.0193 THREADED GLENOID BASEPLATE Ø27X35 (K171058) LOT 185296: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-AUG-2018. EXPIRATION DATE: 2023-AUG-21. 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

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1742965 REVERSE SHOULDER SYSTEM 04.01.0127 HUMERAL REVERSE HC LINER Ø42/+6MM SHOULDER HUMERAL REVERSE HC LINER PHX MEDACTA INTERNATIONAL SA 04.01.0127 179122 07630040706346

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention