BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X15

    MDR report key: 17669144 · Received September 1, 2023

    Report

    Report Number
    3005180920-2023-00681
    Event Type
    Injury
    Date Received
    September 1, 2023
    Date of Event
    August 11, 2023
    Report Date
    October 18, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706414
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: FROM THE VISUAL INSPECTION OF THE RETURNED DEVICES, IT IS POSSIBLE TO ESTABLISH TAHT THE EXPLANTS DO NOT SHOW ANYTHING TO BE HIGHLIGHTED. INFORMATION OF THE FU: DATA OF RETURNED DEVICES: 20 SEPTEMBER 2023. VISUAL INSPECTION OF THE DEVICES.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 16-AUG-2023. LOT 2242347: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JAN-2023. EXPIRATION DATE: 2028-01-10. 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. ADDITIONAL DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON 16-AUG-2023: REVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE 39XØ27 (K170452) LOT 2240240: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-NOV-2022. EXPIRATION DATE: 2027-11-16. 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 04.01.0161 GLENOID POLYAXIAL LOCKING SCREW - L30 (K170452) LOT 2244673: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-DIC-2022. EXPIRATION DATE: 2027-12-01. 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 04.01.0157 GLENOID POLYAXIAL LOCKING SCREW - L14 (K170452) LOT 2244669: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-DEC-2022. EXPIRATION DATE: 2027-12-05. 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 04.01.0006 STD HUMERAL DIAPHYSIS - CEMENTLESS - 11 (K170452) LOT 2117678: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-MAR-2022. EXPIRATION DATE: 2027-03-06. 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 2219868: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JAN-2023. EXPIRATION DATE: 2027-12-27. 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. REVIEW FOR REVERSE SHOULDER SYSTEM 04.01.0123 HUMERAL REVERSE HC LINER Ø39/+3MM (K170452) LOT 2237445: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 4-NOV-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

    AT ABOUT 4 MONTHS FROM THE PRIMARY, REVISION SURGERY DUE TO INFECTION. THE SURGEON REVISED ALL THE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182795 REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X15 SHOULDER GLENOID BASEPLATE PHX MEDACTA INTERNATIONAL SA 2242347 07630040706414

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention