BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMICAL SHOULDER SYSTEM METAL HUMERAL HEAD Ø46

    MDR report key: 16723117 · Received April 12, 2023

    Report

    Report Number
    3005180920-2023-00237
    Event Type
    Injury
    Date Received
    April 12, 2023
    Date of Event
    March 13, 2023
    Report Date
    April 12, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWS
    UDI-DI
    07630040713160
    PMA / PMN Number
    K170910
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20 MARCH 2023: LOT 1903164: (B)(4) MANUFACTURED AND RELEASED ON 30-JULY-2019. EXPIRATION DATE: 2024-07-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED BATCH REVIEWS PERFORMED ON 20 MARCH 2023: ANATOMICAL SHOULDER SYSTEM 04.01.0089 DOUBLE ECCENTER (K170910) LOT 1903973: (B)(4) MANUFACTURED AND RELEASED ON 18-SEP-2019. EXPIRATION DATE: 2024-09-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ANATOMICAL SHOULDER SYSTEM 04.01.0029 HUMERAL ANATOMICAL METAPHYSIS - CEMENTLESS - 135° - 12 (K170910) LOT 1811030: (B)(4) MANUFACTURED AND RELEASED ON 21-FEB-2019. EXPIRATION DATE: 2024-02-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ANATOMICAL SHOULDER SYSTEM 04.01.0133 HC PEGGED GLENOID Ø50 (K170910) LOT 184441: (B)(4) MANUFACTURED AND RELEASED ON 04-FEB-2019. EXPIRATION DATE: 2024-01-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 3 YEARS 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A TORN ROTATOR CUFF AND THE CAUSE IS UNKNOWN. THE SURGEON CONVERTED THE PATIENT FROM ANATOMIC TO REVERSE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211265 ANATOMICAL SHOULDER SYSTEM METAL HUMERAL HEAD Ø46 SHOULDER HUMERAL HEAD KWS MEDACTA INTERNATIONAL SA 04.01.0093 1903164 07630040713160

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention