BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 17037725 · Received June 1, 2023

    Report

    Report Number
    3005180920-2023-00410
    Event Type
    Injury
    Date Received
    June 1, 2023
    Date of Event
    May 9, 2023
    Report Date
    June 1, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805158
    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 16 MAY 2023: LOT 2108058: 120 ITEMS MANUFACTURED AND RELEASED ON 16-SEP-2021. EXPIRATION DATE: 2026-SEP-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 107 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 1 SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED CUP: MPACT 01.32.150DH ACETABULAR SHELL Ø50 TWO-HOLES (K132879) LOT 2218064: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-NOV-2022. EXPIRATION DATE: 2027-OCT-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 23 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LINER: MPACT 01.32.3241HCAT HOODED PE HC LINER Ø32/D (K132879) LOT 2218086: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-SEP-2022. EXPIRATION DATE: 2027-SEP-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 16 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 1 SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. STEM: SMS SOLID 01.36.044 SMS SOLID STEM STD SIZUE 4 (K181693) LOT 2106261: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-SEP-2021. EXPIRATION DATE: 2026-SEP-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 29 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. SCREWS: MPACT 01.43.0025 CANCELLOUS BONE SCREW Ø 6,5 L 25 (K200391) LOT 2216103: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-OCT-2022. EXPIRATION DATE: 2027-SEP-26. 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 CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 2 MONTHS AND 10 DAYS AFTER THE PRIMARY SURGERY, THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132261 COCR BALL HEAD 12/14 Ø 32 SIZE S -3.5 HIP BALL HEAD JDI MEDACTA INTERNATIONAL SA 01.25.021 2108058 07630030805158

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention