BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: COCR 01.25.123 COCR BALL HEAD 12/14 Ø 22 SIZE M 0

    MDR report key: 17194743 · Received June 23, 2023

    Report

    Report Number
    3005180920-2023-00463
    Event Type
    Injury
    Date Received
    June 23, 2023
    Date of Event
    May 25, 2023
    Report Date
    June 23, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805479
    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 05-JUN-2023. LOT 2214566: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-SEP-2022. EXPIRATION DATE: 2027-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 9 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED: LINER: MPACT 01.26.2246MHC DOUBLE MOBILITY HC LINER 22.2/DMC (K092265) LOT 2218116: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-OCT-2022. EXPIRATION DATE: 2027-09-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. LINER: MPACT DM 01.32.3844CF DM CONVERTER TIN COATED E/DMC (K211891) LOT 2215461: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-NOV-2022. EXPIRATION DATE: 2027-10-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 7 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO OTHER SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853889 BALL HEADS: COCR 01.25.123 COCR BALL HEAD 12/14 Ø 22 SIZE M 0 HIP COCR BALL HEAD JDI MEDACTA INTERNATIONAL SA 01.25.123 2214566 07630030805479

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention