BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 20555191 · Received October 29, 2024

    Report

    Report Number
    3005180920-2024-00885
    Event Type
    Injury
    Date Received
    October 29, 2024
    Date of Event
    October 2, 2024
    Report Date
    October 29, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706292
    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 08 OCTOBER 2024 LOT 2317706: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-NOV-2023. EXPIRATION DATE: 2028-11-13. 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 COMPONENTS INVOLVED: BATCH REVIEW PERFORMED ON 08 OCTOBER 2024 REVERSE SHOULDER SYSTEM 04.01.0170 GLENOSPHERE 39XØ24.5 (K170452) LOT. 2317716: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-DEC-2023. EXPIRATION DATE: 2028-11-19. 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. BATCH REVIEW PERFORMED ON 08 OCTOBER 2024 REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT. 2313421A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-NOV-2023. EXPIRATION DATE: 2028-11-01. 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. BATCH REVIEW PERFORMED ON 08 OCTOBER 2024 REVERSE SHOULDER SYSTEM 04.01.0184 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 11 (K180089) LOT. 2311302: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUL-2023. EXPIRATION DATE: 2028-06-25. 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. BATCH REVIEW PERFORMED ON 08 OCTOBER 2024 REVERSE SHOULDER SYSTEM 04.01.0301 GRS BASEPLATE - Ø24.5X20 +3MM (K213459) LOT. 2314207: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-NOV-2023. EXPIRATION DATE: 2028-11-04. 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. BATCH REVIEW PERFORMED ON 08 OCTOBER 2024 REVERSE SHOULDER SYSTEM 04.01.0157 GLENOID POLYAXIAL LOCKING SCREW - L14 (K170452) LOT. 2302395: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-APR-2023. EXPIRATION DATE: 2028-03-12. 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. BATCH REVIEW PERFORMED ON 08 OCTOBER 2024 REVERSE SHOULDER SYSTEM 04.01.0161 GLENOID POLYAXIAL LOCKING SCREW - L30 (K170452) LOT. 2247096: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-FEB-2023. EXPIRATION DATE: 2028-01-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 08 OCTOBER 2024 REVERSE SHOULDER SYSTEM 04.01.0162 GLENOID POLYAXIAL LOCKING SCREW - L34 (K170452) LOT. 2203339: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 3-MAY-2022. EXPIRATION DATE: 2027-04-10. 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.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING TIGHTNESS. THE SURGEON CHOSE TO DECREASE LATERALIZATION, BY REVISING THE LATERALIZED GLENOSPHERE TO A STANDARD GLENOSPHERE. THE SURGEON ALSO REVISED THE LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2024, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND REIMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929624 SHOULDER SYSTEM SHOULDER REVERSE LINER PHX MEDACTA INTERNATIONAL SA 04.01.0122 2317706 07630040706292

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention