BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE 39XØ27

    MDR report key: 13236099 · Received January 12, 2022

    Report

    Report Number
    3005180920-2022-00005
    Event Type
    Injury
    Date Received
    January 12, 2022
    Date of Event
    December 13, 2021
    Report Date
    January 12, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706605
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20 DECEMBER 2021: LOT 2004025: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-APR-2021. EXPIRATION DATE: 2026-04-11. 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. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 20 DECEMBER 2021: REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT 2004007: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAY-2021. EXPIRATION DATE: 2026-04-27. 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 04.01.0183 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 10 (K180089) LOT 2103578: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-APR-2021. EXPIRATION DATE: 2026-04-19. 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 04.01.0123 HUMERAL REVERSE HC LINER Ø39/+3MM (K170452) LOT 2103242: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2021. EXPIRATION DATE: 2026-05-16. 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 · 0

    THE PATIENT CAME IN 2 YEARS AND 3 MONTHS AFTER THE PRIMARY SURGERY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON EXPLANTED THE STEM, POLY, METAPHYSIS, GLENOSPHERE AND PERFORMED A WASHOUT, THEN REIMPLANTED THE STEM, METAPHYSIS, POLY, GLENOSPHERE WITH ANTIBIOTIC BEADS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732110 REVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE 39XØ27 GLENOSPHERE PHX MEDACTA INTERNATIONAL SA 04.01.0173 2004025 07630040706605

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention