BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: COCR BALL HEAD 12/14 Ø 28 SIZE M 0

    MDR report key: 20157866 · Received September 6, 2024

    Report

    Report Number
    3005180920-2024-00732
    Event Type
    Injury
    Date Received
    September 6, 2024
    Date of Event
    August 14, 2024
    Report Date
    September 6, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805110
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 23 AUG 2024 LOT 2307377: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-MAY-2023. EXPIRATION DATE: 2028-04-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 52 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 23 AUG 2024. BALL HEADS: BIPOLAR HEAD 25060.2851 BIPOLAR HEAD Ø28X51 (K091967) LOT 2245354: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-MAY-2023. EXPIRATION DATE: 2028-04-18. 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 27 AUG 2024 STEM: MASTERLOC 01.39.411 CEMENTLESS TI COATED LAT PLUS STEM SIZE 11 (K173267) LOT 2304304: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-JUL-2023. EXPIRATION DATE: 2028-06-21. 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 2 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE MEDACTA COCR, BIPOLAR HEAD AND STEM AND REVISED THE COMPETITOR CUP AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2041681 BALL HEADS: COCR BALL HEAD 12/14 Ø 28 SIZE M 0 FEMORAL HEAD JDI MEDACTA INTERNATIONAL SA 2307377 07630030805110

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male Required Intervention