BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø22X15

    MDR report key: 10069378 · Received May 19, 2020

    Report

    Report Number
    3005180920-2020-00283
    Event Type
    Injury
    Date Received
    May 19, 2020
    Date of Event
    January 31, 2018
    Report Date
    May 19, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706353
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 29 APRIL 2020: LOT 175026: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-NOV-2017. EXPIRATION DATE: 2022-10-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED: BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 29 APRIL 2020: SHOULDER SYSTEM 04.01.0006 STD HUMERAL DIAPHYSIS - CEMENTLESS - 11 (K170452). LOT 172245: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-AUG-2017. EXPIRATION DATE: 2022-07-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0159 GLENOID POLYAXIAL LOCKING SCREW - L22 (K170452). LOT 174282: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-NOV-2017. EXPIRATION DATE: 2022-11-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452). LOT 174647: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-NOV-2017. EXPIRATION DATE: 2022-10-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0167 GLENOSPHERE 32XØ22 (K170452). LOT 163793: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-DEC-2016. EXPIRATION DATE: 2021-10-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0116 HUMERAL REVERSE HC LINER Ø32/+0MM (K170452). LOT 173414: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JUN-2017. EXPIRATION DATE: 2022-06-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0160 GLENOID POLYAXIAL LOCKING SCREW - L26 (K170452). LOT 174283: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-OCT-2017. EXPIRATION DATE: 2022-10-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN 2 YEARS AND 3 MONTHS AFTER 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
    533753 REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø22X15 SHOULDER GLENOID BASEPLATE PHX MEDACTA INTERNATIONAL SA 04.01.0148 175026 07630040706353

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention