BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 36/+0MM

    MDR report key: 11900859 · Received May 28, 2021

    Report

    Report Number
    3005180920-2021-00450
    Event Type
    Injury
    Date Received
    May 28, 2021
    Date of Event
    May 1, 2021
    Report Date
    May 28, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706261
    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 ON 07 MAY 2021: LOT 1910872: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-MAR-2020. EXPIRATION DATE: 2025-02-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON 07 MAY 2021: REVERSE SHOULDER SYSTEM 04.01.0006 STD HUMERAL DIAPHYSIS - CEMENTLESS - 11 (K170452) LOT 1903916: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-SEP-2019. EXPIRATION DATE: 2024-08-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT 1910098: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-MAY-2020. EXPIRATION DATE: 2025-04-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0169 GLENOSPHERE 36XØ24.5 (K170452) LOT 1910099: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-MAY-2020. EXPIRATION DATE: 2025-05-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0161 GLENOID POLYAXIAL LOCKING SCREW - L30 (K170452) LOT 1811902: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAR-2019. EXPIRATION DATE: 2024-03-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0191 THREADED GLENOID BASEPLATE Ø24.5X30 (K171058 ) LOT 1811893: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUL-2019. EXPIRATION DATE: 2024-07-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0159 GLENOID POLYAXIAL LOCKING SCREW - L22 (K170452) LOT 184567: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-APR-2019. EXPIRATION DATE: 2024-04-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED THE HARDWARE, AND IMPLANTED A SPACER WITH ANTIBIOTIC CEMENT 6 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801341 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 36/+0MM SHOULDER LINER PHX MEDACTA INTERNATIONAL SA 04.01.0119 1910872 07630040706261

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention