BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMICAL SHOULDER SYSTEM HC PEGGED GLENOID 42

    MDR report key: 10718019 · Received October 22, 2020

    Report

    Report Number
    3005180920-2020-00731
    Event Type
    Injury
    Date Received
    October 22, 2020
    Date of Event
    September 24, 2020
    Report Date
    October 22, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWS
    UDI-DI
    07630040713245
    PMA / PMN Number
    K170910
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 05 OCTOBER 2020 LOT 182673: 66 ITEMS MANUFACTURED AND RELEASED ON 16-AUG-2018. EXPIRATION DATE: 2023-07-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 38 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 05 OCTOBER 2020 ANATOMICAL SHOULDER SYSTEM 04.01.0092 METAL HUMERAL HEAD Ø44 (K170910) LOT. 1710136 LOT 1710136: 53 ITEMS MANUFACTURED AND RELEASED ON 24-MAY-2018. EXPIRATION DATE: 2023-05-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 40 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ANATOMICAL SHOULDER SYSTEM 04.01.0089 DOUBLE ECCENTER (K170910) LOT. 189741 LOT 189741: 101 ITEMS MANUFACTURED AND RELEASED ON 13-MAR-2019. EXPIRATION DATE: 2024-03-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 94 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. 1710036 LOT 1710036: 80 ITEMS MANUFACTURED AND RELEASED ON 25-MAY-2018. EXPIRATION DATE: 2023-05-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 40 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ANATOMICAL SHOULDER SYSTEM 04.01.0003 STD HUMERAL DIAPHYSIS - CEMENTLESS - 8 (K170452) LOT. 176936 LOT 176936: 80 ITEMS MANUFACTURED AND RELEASED ON 30-NOV-2017. EXPIRATION DATE: 2022-11-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 66 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 YEAR AND 3 MONTHS AFTER PRIMARY SURGERY, REPORTING PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED ALL ANATOMIC COMPONENTS TO REVERSE COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1184277 ANATOMICAL SHOULDER SYSTEM HC PEGGED GLENOID 42 ANATOMICAL SHOULDER HC PEGGED GLENOID KWS MEDACTA INTERNATIONAL SA 04.01.0129 182673 07630040713245

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention