BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 21974457 · Received May 7, 2025

    Report

    Report Number
    3005180920-2025-00381
    Event Type
    Injury
    Date Received
    May 7, 2025
    Date of Event
    April 7, 2025
    Report Date
    June 6, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWS
    UDI-DI
    07630040715959
    PMA / PMN Number
    K180089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW NO DEVICES LOT HAVE BEEN RECEIVED, NOR OTHER ADDITIONAL INFORMATION ABOUT THE CASE. A FOLLOW UP WILL BE PERFORMED IF MORE INFO ABOUT THE INCIDENT WILL BE AVAILABLE. OTHER DEVICES INVOLVED REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) REVERSE SHOULDER SYSTEM 04.01.0122 HUMERAL REVERSE HC LINER Ø39/+0MM (K170452) REVERSE SHOULDER SYSTEM 04.01.0155 GLENOID BASEPLATE - Ø27X25 (K170452) REVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE - Ø39X27 (K170452) 2X REVERSE SHOULDER SYSTEM 04.01.0162 GLENOID POLYAXIAL LOCKING SCREW - L34 (K170452) INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20-MAY-2025 15 ITEMS MANUFACTURED AND RELEASED ON 12-OCT-2020. EXPIRATION DATE: 01-OCT-2025. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 12 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT. 2240211. BATCH REVIEW PERFORMED ON 20-MAY-2025. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-FEB-2023. EXPIRATION DATE: 07-FEB-2028. 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 04.01.0122 HUMERAL REVERSE HC LINER Ø39/+0MM (K170452) LOT. 2243888 BATCH REVIEW PERFORMED ON 20-MAY-2025 90 ITEMS MANUFACTURED AND RELEASED ON 06-FEB-2023. EXPIRATION DATE: 22-JAN-2028. 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 04.01.0155 GLENOID BASEPLATE - Ø27X25 (K170452) LOT 2242350 BATCH REVIEW PERFORMED ON 20-MAY-2025 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-MAR-2023. EXPIRATION DATE: 22-FEB-2028. 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 04.01.0173 GLENOSPHERE - Ø39X27 (K170452) LOT 2242330 BATCH REVIEW PERFORMED ON 20-MAY-2025 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-DEC-2022. EXPIRATION DATE: 24-NOV-2027. 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. 2X REVERSE SHOULDER SYSTEM 04.01.0162 GLENOID POLYAXIAL LOCKING SCREW - L34 (K170452) LOT 2244675 BATCH REVIEW PERFORMED ON 20-MAY-2025 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-DEC-2022. EXPIRATION DATE: 01-DEC-2027. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. THE TWO SCREWS ARE INVOLVED IN THIS CASE.

    Description of Event or Problem · 0

    AT ABOUT 7 MONTHS AFTER PRIMARY, THE PATIENT HAS BEEN REVISED DUE TO INFECTION. SURGERY COMPLETED SUCCESSFULLY. ALL SHOULDER DEVICES REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449907 SHOULDER SYSTEM REVERSE SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 14 KWS MEDACTA INTERNATIONAL SA 04.01.0187 2006575 07630040715959

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention