BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X25

    MDR report key: 9321301 · Received November 14, 2019

    Report

    Report Number
    3005180920-2019-00958
    Event Type
    Injury
    Date Received
    November 14, 2019
    Date of Event
    October 17, 2019
    Report Date
    February 12, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706421
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 25 OCTOBER 2019: LOT 175039: 100 ITEMS MANUFACTURED AND RELEASED ON 07-MAR-2018. EXPIRATION DATE: 2023-02-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 65 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH 3 OTHER SIMILAR EVENTS. OTHER IMPLANTS INVOLVED IN THE COMPLAINT, BATCH REVIEW PERFORMED ON 25 OCTOBER 2019: REVERSE SHOULDER SYSTEM 04.01.0162 GLENOID POLYAXIAL LOCKING SCREW - L34 LOT. 179106 SN N/A LOT 179106: 150 ITEMS MANUFACTURED AND RELEASED ON 23-APR-2018. EXPIRATION DATE: 2023-04-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 105 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. 2 DEVICES OF THIS LOT INVOLVED IN THIS COMPLAINT. REVERSE SHOULDER SYSTEM 04.01.0161 GLENOID POLYAXIAL LOCKING SCREW - L30 LOT. 182475 LOT 182475: 450 ITEMS MANUFACTURED AND RELEASED ON 04-SEPT-2018. EXPIRATION DATE: 2023-08-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 368 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0163 GLENOID POLYAXIAL LOCKING SCREW - L38 LOT. 174750 LOT 174750: 149 ITEMS MANUFACTURED AND RELEASED ON 01-MAR-2018. EXPIRATION DATE: 2023-02-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 81 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0162 GLENOID POLYAXIAL LOCKING SCREW - L34 LOT. 174748 LOT 174748: 200 ITEMS MANUFACTURED AND RELEASED ON 30-JUN-2018. EXPIRATION DATE: 2023-01-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 148 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR EVEN REPORTED. REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° LOT. 174654 LOT 174654: 104 ITEMS MANUFACTURED AND RELEASED ON 20-MAR-2018. EXPIRATION DATE: 2023-03-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 99 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0004 STD HUMERAL DIAPHYSIS - CEMENTLESS - 9 LOT. 179096 LOT 179096: 20 ITEMS MANUFACTURED AND RELEASED ON 29-MAR-2018. EXPIRATION DATE: 2023-03-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 12 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0127 HUMERAL REVERSE HC LINER Ø42/+6MM LOT. 179984 LOT 179984: 120 ITEMS MANUFACTURED AND RELEASED ON 24-APR-2018. EXPIRATION DATE: 2023-04-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 17 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY 4 MONTHS AFTER PRIMARY FOR INFECTION, ALL HARDWARE REMOVED SUCCESSFULLY. THIS PATIENT COMES FROM A VERY COMPLEX CLINICAL HISTORY WITH MULTIPLE PRECEDENT INTERVENTION ON THE SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1116303 REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X25 SHOULDER GLENOID BASEPLATE Ø27X25 PHX MEDACTA INTERNATIONAL SA 04.01.0155 175039 07630040706421

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention