BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø36/E

    MDR report key: 19566894 · Received June 19, 2024

    Report

    Report Number
    3005180920-2024-00430
    Event Type
    Injury
    Date Received
    June 19, 2024
    Date of Event
    May 16, 2024
    Report Date
    June 19, 2024
    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 28-MAY-2024. LOT 2317569: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-AUG-2023. EXPIRATION DATE: 2028-08-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON 28-MAY-2024: CUP: MPACT 3D METAL 01.38.052DH ACETABULAR SHELL 52 TWO-HOLE (K171966) LOT 2335545: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-SEP-2023. EXPIRATION DATE: 2028-09-07. 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. BALL HEADS: MECTACER 01.29.208 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 (K112115) LOT 2336694: 195 ITEMS MANUFACTURED AND RELEASED ON 13-OCT-2023. EXPIRATION DATE: 2028-09-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 187 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. INVESTIGATION PERFORMED BY MEDACTA HIP R&D PROJECT MANAGER: THE IMAGES SHOW THE CUP JUST EXPLANTED, WITH BLOOD AND BONE TISSUE ON ITS SURFACE, NO OTHER DETAILS ARE EVIDENCED. FROM THE RECEIVED IMAGES AND INFORMATION IT IS NOT POSSIBLE TO DETERMINE ANY ROOT CAUSE OF THE EVENT.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2023. ON (B)(6) 2024 THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED SUCCESSFULLY THE HEAD AND LINER. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO JOINT LUXATION AND THE CAUSE IS UNKNOWN. THE CUP WAS MALPOSITIONED IN THE PRIMARY SURGERY AND PROBABLY THIS CAUSED THE DISLOCATION. THE SURGEON REVISED THE HEAD, CUP AND LINER AND IMPLANTED A DOUBLE MOBILITY CUP AND LINER AND BALL HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT BONE QUALITY WAS EXCELLENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705170 LINER: MPACT FLAT PE HC LINER Ø36/E HIP LINER LPH MEDACTA INTERNATIONAL SA 2317569 07630030812118

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention