BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMICAL SHOULDER SYSTEM HC PEGGED GLENOID 44

    MDR report key: 11445733 · Received March 9, 2021

    Report

    Report Number
    3005180920-2021-00181
    Event Type
    Injury
    Date Received
    March 9, 2021
    Date of Event
    February 8, 2021
    Report Date
    March 9, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWS
    UDI-DI
    07630040713252
    PMA / PMN Number
    K170910
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15 FEBRUARY 2021: LOT 181488: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JUNE-2018. EXPIRATION DATE: 2023-06-03. 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. ANOTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 15 FEBRUARY 2021: ANATOMICAL SHOULDER SYSTEM 04.01.0029 HUMERAL ANATOMICAL METAPHYSIS - CEMENTLESS - 135° - 12 (K170910)LOT. 1811030: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-FEB-2019. EXPIRATION DATE: 2024-02-04. 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. ANATOMICAL SHOULDER SYSTEM 04.01.0089 DOUBLE ECCENTER (K170910)LOT. 1905791: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-OCT-2019. EXPIRATION DATE: 2024-10-07. 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. ANATOMICAL SHOULDER SYSTEM 04.01.0093 METAL HUMERAL HEAD Ø46 (K170910)LOT. 183790: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-NOV-2018. EXPIRATION DATE: 2023-11-06. 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

    REVISION SURGERY DUE TO INSTABILITY 8 MONTHS AFTER THE PRIMARY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED ALL ANATOMIC COMPONENTS (EXCEPT THE STEM) TO REVERSE COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340179 ANATOMICAL SHOULDER SYSTEM HC PEGGED GLENOID 44 SHOULDER PROSTHESIS PEGGED GLENOID KWS MEDACTA INTERNATIONAL SA 04.01.0130 181488 07630040713252

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention