BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø28/B

    MDR report key: 16173753 · Received January 16, 2023

    Report

    Report Number
    3005180920-2022-01012
    Event Type
    Injury
    Date Received
    January 16, 2023
    Date of Event
    December 28, 2022
    Report Date
    January 16, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030811531
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 30-DEC-2022. LOT: 2201898: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-FEB-2022. EXPIRATION DATE: 2027-02-06. 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 01.29.201 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5 LOT: 2204265: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JUN-2022. EXPIRATION DATE: 2027-06-02. 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 1 MONTH AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION, HEAD FROM THE LINER, AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE CUP AND LINER WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1426713 LINER: MPACT FLAT PE HC LINER Ø28/B HIP ACETABULAR LINER LPH MEDACTA INTERNATIONAL SA 01.32.2837HCT 2201898 07630030811531

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention