BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X30

    MDR report key: 9375797 · Received November 26, 2019

    Report

    Report Number
    3005180920-2019-01008
    Event Type
    Injury
    Date Received
    November 26, 2019
    Date of Event
    November 4, 2019
    Report Date
    November 26, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040715478
    PMA / PMN Number
    K171058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 12 NOVEMBER 2019: LOT 183704: 102 ITEMS MANUFACTURED AND RELEASED ON 10-SEP-2018. EXPIRATION DATE: 2023-08-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 77 ITEM OF THE SAME LOT HAVE BEEN ALREADY SOLD. ADDITIONAL IMPLANTS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON (B)(6) 2019. REVERSE SHOULDER SYSTEM 04.01.0157 GLENOID POLYAXIAL LOCKING SCREW - L14 (K170452) LOT. 174739 LOT 174739: 200 ITEMS MANUFACTURED AND RELEASED ON 21-DIC-2017. EXPIRATION DATE: 2022-12-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 125 ITEM OF THE SAME LOT HAVE BEEN ALREADY SOLD. REVERSE SHOULDER SYSTEM 04.01.0159 GLENOID POLYAXIAL LOCKING SCREW - L22 (K170452) LOT. 179970. LOT 179970: 140 ITEMS MANUFACTURED AND RELEASED ON 17-MAY-2018. EXPIRATION DATE: 2023-05-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 103 ITEM OF THE SAME LOT HAVE BEEN ALREADY SOLD. REVERSE SHOULDER SYSTEM 04.01.0161 GLENOID POLYAXIAL LOCKING SCREW - L30 (K170452) LOT. 184569 (2 PIECES). LOT 184569: 303 ITEMS MANUFACTURED AND RELEASED ON 15-JAN-2019. EXPIRATION DATE: 2023-12-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 180 ITEM OF THE SAME LOT HAVE BEEN ALREADY SOLD. REVERSE SHOULDER SYSTEM 04.01.0171 GLENOSPHERE 42XØ24.5 (K170452) LOT. 183802 LOT 183802: 139 ITEMS MANUFACTURED AND RELEASED ON 13-FEB-2019. EXPIRATION DATE: 2024-01-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 7 ITEM OF THE SAME LOT HAVE BEEN ALREADY SOLD. REVERSE SHOULDER SYSTEM 04.01.0006 STD HUMERAL DIAPHYSIS - CEMENTLESS - 11 (K170452) LOT. 178132. LOT 178132: 70 ITEMS MANUFACTURED AND RELEASED ON 29-MAR-2018. EXPIRATION DATE: 2023-03-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 46 ITEM OF THE SAME LOT HAVE BEEN ALREADY SOLD. REVERSE SHOULDER SYSTEM 04.01.0126 HUMERAL REVERSE HC LINER Ø42/+3MM (K170452) LOT. 189838 LOT 189838: 52 ITEMS MANUFACTURED AND RELEASED ON 25-JAN-2019. EXPIRATION DATE: 2024-01-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 17 ITEM OF THE SAME LOT HAVE BEEN ALREADY SOLD.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED AFTER 3 MONTHS FROM THE PRIMARY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1172117 REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X30 THREADED GLENOID BASEPLATE PHX MEDACTA INTERNATIONAL SA 183704 07630040715478

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention