BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: COCR BALL HEAD 12/14 Ø 36 SIZE S -3.5

    MDR report key: 18985245 · Received March 27, 2024

    Report

    Report Number
    3005180920-2024-00150
    Event Type
    Injury
    Date Received
    March 27, 2024
    Date of Event
    February 27, 2024
    Report Date
    March 27, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805202
    PMA / PMN Number
    K080885
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 06 MARCH 2024 LOT 2312141: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-AUG-2023. EXPIRATION DATE: 2028-07-18. 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. ADDITIONAL INVOLVED IMPLANT BATCH REVIEW PERFORMED ON 06 MARCH 2024 ON STEM: MASTERLOC 01.39.207 CEMENTLESS TI COATED LAT STEM SIZE 7 (K151531) LOT. 2218191. LOT 2218191: (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 WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY HIP SURGERY ON 2023. ON (B)(6) 2023, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE MEDACTA HEAD AND COMPETITOR LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENLTLY ON (B)(6) 2024 , 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
    1929095 BALL HEADS: COCR BALL HEAD 12/14 Ø 36 SIZE S -3.5 HIP COCR BALL HEAD JDI MEDACTA INTERNATIONAL SA 2312141 07630030805202

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention