BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMICAL SHOULDER SYSTEM HC PEGGED GLENOID 48

    MDR report key: 12506482 · Received September 21, 2021

    Report

    Report Number
    3005180920-2021-00759
    Event Type
    Injury
    Date Received
    September 21, 2021
    Date of Event
    August 24, 2021
    Report Date
    September 21, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWS
    UDI-DI
    07630040713276
    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 02.SEPT.2021: LOT 1901917: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUNE-2019. EXPIRATION DATE: 2024-JUNE-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT OTHER SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED IN THE EVENT: ANATOMICAL SHOULDER SYSTEM 04.01.0182 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 9 (K180089) LOT. 1907753. LOT 1907753: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-OCT-2019. EXPIRATION DATE: 2024-OCT-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT OTHER SIMILAR REPORTED EVENTS. ANATOMICAL SHOULDER SYSTEM 04.01.0026 HUMERAL ANATOMICAL METAPHYSIS - CEMENTLESS - 135° - 9 (K170910) LOT. 1905776. LOT 1905776: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-NOV-2019. EXPIRATION DATE: 2024-NOV-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT OTHER SIMILAR REPORTED EVENTS. ANATOMICAL SHOULDER SYSTEM 04.01.0094 METAL HUMERAL HEAD Ø48 (K170910) LOT. 1811915. LOT 1811915: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-APR-2019. EXPIRATION DATE: 2024-APR-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT OTHER SIMILAR REPORTED EVENTS. ANATOMICAL SHOULDER SYSTEM 04.01.0089 DOUBLE ECCENTER (K170910) LOT. 2001146. LOT 2001146: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JUL-2020. EXPIRATION DATE: 2025-JUN-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT OTHER SIMILAR REPORTED EVENTS.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1407785 ANATOMICAL SHOULDER SYSTEM HC PEGGED GLENOID 48 SHOULDER GLENOID KWS MEDACTA INTERNATIONAL SA 04.01.0132 1901917 07630040713276

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention