BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 20732100 · Received November 20, 2024

    Report

    Report Number
    3005180920-2024-00959
    Event Type
    Injury
    Date Received
    November 20, 2024
    Date of Event
    October 21, 2024
    Report Date
    November 20, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706179
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 30-OCT-2024. LOT 1811886: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2019. EXPIRATION DATE: 2024-05-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS REVISED, BATCH REVIEW PERFORMED ON 30-OCT-2024: REVERSE SHOULDER SYSTEM 04.01.0119 HUMERAL REVERSE HC LINER Ø36/+0MM (K170452) LOT 189832: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-FEB-2019. EXPIRATION DATE: 2024-01-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0169 GLENOSPHERE - Ø36X24.5 (K170452) LOT 179109: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-MAR-2018. EXPIRATION DATE: 2023-03-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0183 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 10 (K180089) LOT 1811909: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-FEB-2019. EXPIRATION DATE: 2024-01-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0190 THREADED GLENOID BASEPLATE Ø24.5X25 (K171058) LOT 183703: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-AUG-2018. EXPIRATION DATE: 2023-08-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0159 GLENOID POLYAXIAL LOCKING SCREW - L22 (K170452) LOT 182474: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-SEP-2018. EXPIRATION DATE: 2023-08-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0161 GLENOID POLYAXIAL LOCKING SCREW - L30 (K170452) LOT 182475: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-SEP-2018. EXPIRATION DATE: 2023-08-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    AT ABOUT 5 YEARS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO COMPETITOR COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2306704 SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0° PHX MEDACTA INTERNATIONAL SA 04.01.0110 1811886 07630040706179

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention