BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 36/+6MM

    MDR report key: 11337935 · Received February 17, 2021

    Report

    Report Number
    3005180920-2021-00123
    Event Type
    Injury
    Date Received
    February 17, 2021
    Date of Event
    January 19, 2021
    Report Date
    February 17, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706285
    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 15.FEBRUARY.2021: LOT 2004291: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-JUL-2020. EXPIRATION DATE: 2025-07-13. 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 IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0111 HUMERAL REVERSE METAPHYSIS +9MM/0¿ (K170452), LOT. 1910965. BATCH REVIEW PERFORMED ON 15.FEBRUARY.2021: LOT 1910965: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JUN-2020. EXPIRATION DATE: 2025-05-28. 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 IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0207 LAT. GLENOSPHERE 36X¿24.5 (K193175) LOT. 189933 BATCH REVIEW PERFORMED ON 15.FEBRUARY.2021: LOT 189933: 55 ITEMS MANUFACTURED AND RELEASED ON 08-MAY-2019. EXPIRATION DATE: 2024-04-23. 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. ADDITIONAL IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0190 THREADED GLENOID BASEPLATE ¿24.5X25 (K171058 ) LOT. 1811892 BATCH REVIEW PERFORMED ON 15.FEBRUARY.2021: LOT 1811892: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUL-2019. EXPIRATION DATE: 2024-07-01. 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 IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0001 STD HUMERAL DIAPHYSIS - CEMENTLESS - 6 (K170452) LOT. 1906537 BATCH REVIEW PERFORMED ON 15.FEBRUARY.2021: LOT 1906537: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-SEP-2019. EXPIRATION DATE: 2024-08-28. 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 1 MONTH AFTER THE PREVIOUS REVISION SURGERY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PREVIOUS REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION( GLENOSPHERE AND LINER REVISED). THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234062 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 36/+6MM REVERSE SHOULDER LINER PHX MEDACTA INTERNATIONAL SA 04.01.0121 2004291 07630040706285

    Patients

    Seq Age Sex Outcome Treatment
    1