BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 21026680 · Received December 27, 2024

    Report

    Report Number
    3005180920-2024-01114
    Event Type
    Injury
    Date Received
    December 27, 2024
    Date of Event
    December 4, 2024
    Report Date
    December 27, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706469
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 12-DEC-2024: LOT 2240567: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-DEC-2022. EXPIRATION DATE: 2027-11-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD, NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: REVISION SURGERY PERFORMED 1 YEAR AND 9 MONTHS AFTER THE PRIMARY RSA DUE TO SUSPECTED SEPTIC LOOSENING AND METALLOSIS ON THE HUMERAL AND GLENOID PART. IF THE LOOSENING IS SEPTIC, THE INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING THA'S. WHILE, WE DO NOT HAVE ENOUGH INFORMATION TO DETERMINE THE ORIGIN OF THE METALLOSIS. PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER: THE PROVIDED PICTURES CONFIRM THE BREAKAGE OF ONE POLYAXIAL SCREW AND THE PRESENCE OF METALLOSIS ON THE BASEPLATE. GIVEN THE INFORMATION AT HAND IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT. ADDITIONAL IMPLANTS INVOLVED: BATCH REVIEW PERFORMED ON 12-DEC-2024 ON REVERSE SHOULDER SYSTEM 04.01.0284 HUMERAL ECCENTRIC REVERSE METAPHYSIS +0MM/+3MM (K210207) LOT. 2239189: LOT 2239189: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-FEB-2023. EXPIRATION DATE: 2028-01-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD, NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 12-DEC-2024 ON REVERSE SHOULDER SYSTEM 04.01.0122 HUMERAL REVERSE HC LINER Ø39/+0MM (K170452) LOT. 2240222: LOT 2240222: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JAN-2023. EXPIRATION DATE: 2027-12-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD, NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 12-DEC-2024 ON REVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE - Ø39X27 (K170452) LOT. 2240241: LOT 2240241: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-DEC-2022. EXPIRATION DATE: 2027-11-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD, NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 12-DEC-2024 ON REVERSE SHOULDER SYSTEM 04.01.0164 GLENOID POLYAXIAL LOCKING SCREW - L42 (K170452) LOT. 2211008: LOT 2211008: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JUN-2022. EXPIRATION DATE: 2027-06-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD, NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 12-DEC-2024 ON REVERSE SHOULDER SYSTEM 04.01.0155 GLENOID BASEPLATE - Ø27X25 (K170452) LOT. 2242351: LOT 2242351: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-FEB-2023. EXPIRATION DATE: 2028-02-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD, NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 12-DEC-2024 ON REVERSE SHOULDER SYSTEM 04.01.0165 GLENOID POLYAXIAL LOCKING SCREW - L46 (K170452) LOT. 2117100: LOT 2117100: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-JAN-2022. EXPIRATION DATE: 2027-01-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD, NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 12-DEC-2024 ON REVERSE SHOULDER SYSTEM 04.01.0182 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 9 (K180089) LOT. 2243577: LOT 2243577: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JAN-2023. EXPIRATION DATE: 2028-01-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD, NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 12-DEC-2024 ON REVERSE SHOULDER SYSTEM 04.01.0201 GLENOID POLYAXIAL NON-LOCKING SCREW - L42 (K181826) LOT. 2246466: LOT 2246466: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-FEB-2023. EXPIRATION DATE: 2028-01-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD, NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED 1 YEAR AND 9 MONTHS AFTER THE PRIMARY SURGERY DUE TO SUSPECTED SEPTIC LOOSENING AND METALLOSIS ON THE HUMERAL AND GLENOID PART. BONE GRAFT USED IN PRIMARY SURGERY. ONE POLYAXIAL SCREW WAS FOUND BROKEN. ALL IMPLANTS WERE REMOVED AND A SPACER WAS PUT IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2510329 SHOULDER SYSTEM SHOULDER GLENOID POLYAXIAL LOCKING SCREW PHX MEDACTA INTERNATIONAL SA 04.01.0159 2240567 07630040706469

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention