BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 10

    MDR report key: 17404478 · Received July 27, 2023

    Report

    Report Number
    3005180920-2023-00614
    Event Type
    Injury
    Date Received
    July 27, 2023
    Date of Event
    July 12, 2023
    Report Date
    September 18, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040715911
    PMA / PMN Number
    K180089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDIITIONAL DEVICES RECEIVED: REVERSE SHOULDER SYSTEM 04.01.0162 GLENOID POLYAXIAL LOCKING SCREW - L34 (K170452) LOT 2118707. REVERSE SHOULDER SYSTEM 04.01.0162 GLENOID POLYAXIAL LOCKING SCREW - L34 (K170452) LOT 2115027. BATCH REVIEW PERFORMED ON 11-SEP-2023. REVERSE SHOULDER SYSTEM 04.01.0162 GLENOID POLYAXIAL LOCKING SCREW - L34 (K170452) LOT 2118707: 198 ITEMS MANUFACTURED AND RELEASED ON 21-FEB-2022. EXPIRATION DATE: 2027-02-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 182 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0162 GLENOID POLYAXIAL LOCKING SCREW - L34 (K170452) LOT 2115027: 222 ITEMS MANUFACTURED AND RELEASED ON 16-DEC-2021. EXPIRATION DATE: 2026-12-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 214 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT LATE INFECTION IN CEMENTLESS RSA, 1 YEAR AND 2 MONTHS AFTER PRIMARY OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING RSA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER. THE EXPLANTS DO NOT SHOW ANY ANOMALIES.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 26-JUL-2023: LOT 2110753: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-SEP-2021. EXPIRATION DATE: 2026-08-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENTS INVOLVED IN THE EVENT: BATCH REVIEW PERFORMED ON 26-JUL-2023: REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K1704529) LOT 2108989: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-FEB-2022. EXPIRATION DATE: 2027-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 26-JUL-2023: REVERSE SHOULDER SYSTEM 04.01.0122 HUMERAL REVERSE HC LINER Ø39/+0MM (K170452) LOT 2118741: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-JAN-2022. EXPIRATION DATE: 2027-01-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 26-JUL-2023: REVERSE SHOULDER SYSTEM 04.01.0155 GLENOID BASEPLATE Ø27X25 (K170452) LOT 2110379: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-NOV-2021. EXPIRATION DATE: 2026-11-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 26-JUL-2023: REVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE 39XØ27 (K170452) LOT. 2003895: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAY-2021. EXPIRATION DATE: 2026-04-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AND 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND RESULTED POSITIVE FOR CURTIBACTERIUM ACNES. THE SURGEON PERFORMED AN ANALGESIC TREATMENT AND REMOVED ALL THE IMPLANTS. THE PATIENT IS UNDER MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663465 REVERSE SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 10 SHOULDER DIAPHYSIS PHX MEDACTA INTERNATIONAL SA 2110753 07630040715911

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention