BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 20797556 · Received November 27, 2024

    Report

    Report Number
    3005180920-2024-00993
    Event Type
    Injury
    Date Received
    November 27, 2024
    Date of Event
    September 24, 2024
    Report Date
    November 27, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706179
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 08 NOVEMBER 2024. LOT 2208698: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-09-2022 EXPIRATION DATE: 2027-09-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. 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 ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 08 NOVEMBER 2024. REVERSE SHOULDER SYSTEM 04.01.0162 GLENOID POLYAXIAL LOCKING SCREW - L34 (K170452) LOT. 2214353. LOT 2214353: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-09-2022 EXPIRATION DATE: 2027-08-22. 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. REVERSE SHOULDER SYSTEM 04.01.0125 HUMERAL REVERSE HC LINER Ø42/+0MM (K170452) LOT. 2204128. LOT 2204128: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-04-2022 EXPIRATION DATE: 2027-03-21. 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 04.01.0151 GLENOID BASEPLATE - Ø24.5X15 (K170452) LOT. 2209624 LOT 2209624: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-08-2022 EXPIRATION DATE: 2027-08-17. 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 04.01.0004 STANDARD HUMERAL DIAPHYSIS - CEMENTLESS - 9 (K170910) LOT. 2215662. LOT 2215662: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-09-2022 EXPIRATION DATE: 2027-08-28. 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 04.01.0171 GLENOSPHERE - Ø42X24.5 (K170452) LOT. 2201464 LOT 2201464: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-05-2022 EXPIRATION DATE: 2027-05-15. 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 04.01.0164 GLENOID POLYAXIAL LOCKING SCREW - L42 (K170452) LOT. 2238992. LOT 2238992: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-11-2022 EXPIRATION DATE: 2027-10-17. 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.

    Description of Event or Problem · 0

    1 YEAR AND 10 MONTHS AFTER PRIMARY THE SURGEON REVISED ALL IMPLANTS DUE TO A DEEP INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2434847 SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS PHX MEDACTA INTERNATIONAL SA 04.01.0110 2208698 07630040706179

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention