BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø40/G

    MDR report key: 16565476 · Received March 17, 2023

    Report

    Report Number
    3005180920-2023-00159
    Event Type
    Injury
    Date Received
    March 17, 2023
    Date of Event
    February 17, 2023
    Report Date
    March 17, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030812286
    PMA / PMN Number
    K122641
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 27-FEB-2023. LOT 2118359: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-DEC-2021. EXPIRATION DATE: 2026-12-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENT INVOLVED: BALL HEADS: MECTACER 01.29.215 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE XL +8 (K1121159 LOT. 2115857: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-MAR-2022. EXPIRATION DATE: 2027-02-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 6 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. 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
    664857 LINER: MPACT FLAT PE HC LINER Ø40/G HIP ACETABUAR LINER LZO MEDACTA INTERNATIONAL SA 01.32.4052HCT 2118359 07630030812286

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention