BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø36/E

    MDR report key: 15995384 · Received December 16, 2022

    Report

    Report Number
    3005180920-2022-00948
    Event Type
    Injury
    Date Received
    December 16, 2022
    Date of Event
    December 1, 2022
    Report Date
    December 16, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812118
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 05-DEC-2022. LOT 2202298: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-MAR-2022. EXPIRATION DATE: 2027-02-27. 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 THE REVIEW. ADDITIONAL DEVICE INVOLVED. BATCH REVIEW PERFORMED ON 05-DEC-2022. BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT 2200870: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-APR-2022. EXPIRATION DATE: 2027-03-31. 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 3 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE MEDACTA 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
    1484419 LINER: MPACT FLAT PE HC LINER Ø36/E HIP SHELL LINER LPH MEDACTA INTERNATIONAL SA 01.32.3644HCT 2202298 07630030812118

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention