BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: COCR COCR BALL HEAD 12/14 Ø 32 SIZE S -3.5

    MDR report key: 16724726 · Received April 12, 2023

    Report

    Report Number
    3005180920-2023-00281
    Event Type
    Injury
    Date Received
    April 12, 2023
    Date of Event
    March 23, 2023
    Report Date
    April 12, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805158
    PMA / PMN Number
    K072857
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2023: LOT 2108058: 120 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2021. EXPIRATION DATE: 2026-09-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 106 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ADDITIONAL COMPONENT INVOLVED: LINER: MPACT 01.32.3241HCAT HOODED PE HC LINER Ø32/D (K132879) LOT. 2218086: 20 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2022. EXPIRATION DATE: 2027-09-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 16 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 1 MONTH FROM PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2284679 BALL HEADS: COCR COCR BALL HEAD 12/14 Ø 32 SIZE S -3.5 HIP FEMORAL HEAD JDI MEDACTA INTERNATIONAL SA 01.25.021 2108058 07630030805158

    Patients

    Seq Age Sex Outcome Treatment
    1 Female