BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0°

    MDR report key: 19069589 · Received April 9, 2024

    Report

    Report Number
    3005180920-2024-00234
    Event Type
    Injury
    Date Received
    April 9, 2024
    Date of Event
    March 19, 2024
    Report Date
    April 9, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706179
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28-MAR-2024: LOT 2003981: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-MAY-2021. EXPIRATION DATE: 2026-04-27. 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. ADDITIONAL DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 28-MAR-2024: REVERSE SHOULDER SYSTEM 04.01.0119 HUMERAL REVERSE HC LINER Ø36/+0MM (K170452) LOT 2114974A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-DEC-2021. EXPIRATION DATE: 2026-11-15. 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 04.01.0148 GLENOID BASEPLATE - Ø22X15 (K170452) LOT 2110372: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-NOV-2021. EXPIRATION DATE: 2026-10-26. 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 04.01.0160 GLENOID POLYAXIAL LOCKING SCREW - L26 (K170452) LOT 2118700: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-MAR-2022. EXPIRATION DATE: 2027-02-10. 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 2118707: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-FEB-2022. EXPIRATION DATE: 2027-02-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0168 GLENOSPHERE - Ø36X22 (K170452) LOT 2101360: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-JUN-2021. EXPIRATION DATE: 2026-05-26. 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 04.01.0183 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 10 (K180089) LOT 2117700: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-APR-2022. EXPIRATION DATE: 2027-03-22. 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.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AND 8 MONTHS AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2288487 REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0° SHOULDER REVERSE METAPHYSIS PHX MEDACTA INTERNATIONAL SA 2003981 07630040706179

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention