BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMICAL SHOULDER SYSTEM 04.01.0130 HC PEGGED GLENOID Ø44

    MDR report key: 14488699 · Received May 24, 2022

    Report

    Report Number
    3005180920-2022-00398
    Event Type
    Injury
    Date Received
    May 24, 2022
    Date of Event
    April 27, 2022
    Report Date
    May 24, 2022
    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 · 0

    BATCH REVIEW PERFORMED ON 29 APRIL 2022. LOT 2006586: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-OCT-2020. EXPIRATION DATE: 2025-09-30. 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 29 APRIL 2022 . ANATOMICAL SHOULDER SYSTEM 04.01.0092 METAL HUMERAL HEAD Ø44 (K170910) LOT 2001820: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JUL-2020. EXPIRATION DATE: 2025-07-17. 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. ANATOMICAL SHOULDER SYSTEM 04.01.0025 HUMERAL ANATOMICAL METAPHYSIS - CEMENTLESS - 135° - 8 (K170910) LOT 1905775: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-NOV-2019. EXPIRATION DATE: 2024-11-18. 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. ANATOMICAL SHOULDER SYSTEM 04.01.0089 DOUBLE ECCENTER (K170910) LOT 2003801: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-SEP-2020. EXPIRATION DATE: 2025-09-15. 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 REPORTING PAIN DUE TO A FAILED SUBSCAPULARIS MUSCLE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE ANATOMIC HEAD, DOUBLE ECCENTER, POLY, AND ANATOMIC METAPHYSIS 9 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166008 ANATOMICAL SHOULDER SYSTEM 04.01.0130 HC PEGGED GLENOID Ø44 ANATOMICAL SHOULDER HC PEGGED GLENOID KWS MEDACTA INTERNATIONAL SA 04.01.0130 2006586 07630040713252

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention