BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 22326363 · Received June 25, 2025

    Report

    Report Number
    3005180920-2025-00559
    Event Type
    Injury
    Date Received
    June 25, 2025
    Date of Event
    May 26, 2025
    Report Date
    June 25, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706605
    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 30 MAY 2025 LOT 2115427: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-FEB-2022. EXPIRATION DATE: 2027-02-09. 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. OTHER DEVICES INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0161 GLENOID POLYAXIAL LOCKING SCREW - L30 (K170452) LOT 2201485: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-MAY-2022. EXPIRATION DATE: 2027-04-10. 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 04.01.0162 GLENOID POLYAXIAL LOCKING SCREW - L34 (K170452) LOT 2236651: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-OCT-2022. EXPIRATION DATE: 2027-09-18. 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. REVERSE SHOULDER SYSTEM 04.01.0123 HUMERAL REVERSE HC LINER Ø39/+3MM (K170452) LOT 2209095: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JUL-2022. EXPIRATION DATE: 2027-06-20. 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. REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT 2212555: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-NOV-2022. EXPIRATION DATE: 2027-10-17. 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. REVERSE SHOULDER SYSTEM 04.01.0002 STANDARD HUMERAL DIAPHYSIS - CEMENTLESS - 7 (K170910) LOT 2215661: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-SEP-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.CM22.013 RECONSTRUCTION GLENOID BASEPLATE LOT. 2244492 (NOT DISTRIBUTED IN US): (B)(4) ITEM MANUFACTURED AND RELEASED ON 05-DEC-2022. EXPIRATION DATE: 2027-11-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. 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.

    Description of Event or Problem · 0

    REVISION SURGERY DUE TO INFECTION AT ABOUT 2 YEARS AND 5 MONTHS FROM THE PRIMARY. NO FINAL IMPLANTS WERE IMPLANTED, ONLY A SPACER BECAUSE OF THE INFECTION. LATER ON, THE SURGEON WILL PUT IN NEW IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1998592 SHOULDER SYSTEM REVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE - Ø39X27 PHX MEDACTA INTERNATIONAL SA 04.01.0173 2115427 07630040706605

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female Required Intervention