BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLENOID RECONSTRUCTION SYSTEM

    MDR report key: 25275465 · Received May 26, 2026

    Report

    Report Number
    3005180920-2026-00495
    Event Type
    Malfunction
    Date Received
    May 26, 2026
    Date of Event
    October 8, 2024
    Report Date
    May 26, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630345710307
    PMA / PMN Number
    K213459
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 4 MAY 2026 REVERSE SHOULDER SYSTEM 04.01.0301 GRS BASEPLATE - D 24.5X20 +3MM (K213459) LOT 2308511: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-APR-2024. EXPIRATION DATE: 24-MAR-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 04.01.0159 GLENOID POLYAXIAL LOCKING SCREW - L22 (K170452) LOT 2408189: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAY-2024. EXPIRATION DATE: 02-MAY-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 04.01.0159 GLENOID POLYAXIAL LOCKING SCREW - L22 (K170452) LOT 2407398: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-MAY-2024. EXPIRATION DATE: 28-APR-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 04.01.0269 SENSITIN GLENOSPHERE 36XD 24.5 (K203755) LOT 2343896: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JUN-2024. EXPIRATION DATE: 05-JUN-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 04.01.0184 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 11 (K180089) LOT 2402686: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-APR-2024. EXPIRATION DATE: 26-MAR-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 2349509: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAY-2024. EXPIRATION DATE: 01-MAY-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 04.01.0119 HUMERAL REVERSE HC LINER D 36/+0MM (K170452) LOT 2401270: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-APR-2024. EXPIRATION DATE: 08-APR-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. ROOT CAUSE:BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE 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

    PATIENT UNDERWENT REVERSE SHOULDER REPLACEMENT IN (B)(6) 2024 AND REQUIRED 5-DAY HOSPITALIZATION. FOLLOWING DISCHARGE AND PHYSIOTHERAPY, THE PATIENT REPORTED PERSISTENT AND WORSENING PAIN. DESPITE MULTIPLE FOLLOW-UP VISITS, NO ISSUES WERE INITIALLY IDENTIFIED BY THE TREATING PHYSICIAN. ABOUT 1 YEAR LATER, MRI REVEALED PRESENCE OF METAL DEBRIS AND DETERIORATION OF THE PROSTHETIC JOINT. SUBSEQUENT BLOOD TESTS CONFIRMED COBALT POISONING. REVISION SURGERY TO REMOVE THE IMPLANT WAS PROPOSED BUT LEFT TO PATIENT DECISION. NO ONGOING MONITORING HAS BEEN ESTABLISHED, AND THE PATIENT IS SEEKING A SECOND OPINION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578117 GLENOID RECONSTRUCTION SYSTEM GRS BASEPLATE - Ø24.5X20 +3MM PHX MEDACTA INTERNATIONAL SA 04.01.0301 2308511 07630345710307

    Patients

    Seq Age Sex Outcome Treatment
    1