BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 24162754 · Received January 23, 2026

    Report

    Report Number
    3005180920-2026-00038
    Event Type
    Injury
    Date Received
    January 23, 2026
    Date of Event
    October 20, 2025
    Report Date
    January 23, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040715935
    PMA / PMN Number
    K180089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 08 JAN 2026. REVERSE SHOULDER SYSTEM 04.01.0185 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 13 LOT. 2408538: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 MAY 2024. EXPIRATION DATE: 07 MAY 2029. 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 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT. 2408551: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09 SEP 2024. EXPIRATION DATE: 25 AUG 2029. 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 04.01.0156 GLENOID BASEPLATE - D 27X35 (K1704529) LOT. 2408186 : (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 JUL 2024. EXPIRATION DATE: 10 JUL 2029. 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 - D 39X27 (K170452) LOT. 2409932: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 SEP 2024. EXPIRATION DATE: 21 AUG 2029. 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 04.01.0122 HUMERAL REVERSE HC LINER D 39/+0MM (K170452) LOT. 2409942: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 JUN 2024. EXPIRATION DATE: 30 MAY 2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH TWO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0162 GLENOID POLYAXIAL LOCKING SCREW - L34 ( K170452) LOT. 2408195: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 MAY 2024. EXPIRATION DATE: 25 APR 2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH A SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0162 GLENOID POLYAXIAL LOCKING SCREW - L34 ( K170452) LOT. 2408195: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 MAY 2024. EXPIRATION DATE: 25 APR 2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH A SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION: LATE INFECTION IN REVERSE TSA, APPROXIMATELY 1 YEAR AFTER PRIMARY OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING TSA&SIZE39;S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES. ROOT CAUSE:LATE INFECTION IN TSA IS A KNOWN POSSIBLE COMPLICATION . 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 WAS PERFORMED APPROXIMATELY ONE YEAR AFTER THE PRIMARY PROCEDURE DUE TO A DEEP INFECTION. ALL IMPLANT COMPONENTS WERE REVISED BY THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228588 SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 13 PHX MEDACTA INTERNATIONAL SA 04.01.0185 2408538 07630040715935

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention