BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø32/E

    MDR report key: 10136933 · Received June 10, 2020

    Report

    Report Number
    3005180920-2020-00313
    Event Type
    Injury
    Date Received
    June 10, 2020
    Date of Event
    May 11, 2020
    Report Date
    June 10, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030811913
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15 MAY 2020 LOT 1905498: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JUN-2019. EXPIRATION DATE: 2024-06-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 15 MAY 2020: BALL HEADS: MECTACER 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 32 SIZE M 0 (K112115) LOT. 180535. LOT 180535: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JUL-2018. EXPIRATION DATE: 2023-07-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    IMMEDIATELY FOLLOWING THE PRIMARY HIP SURGERY AND WHILE THE PATIENT WAS IN POST-OP, THE HEAD DISLOCATED FROM THE LINER. THE SURGEON REVISED THE SIZE 4 STEM TO A SIZE 6 STEM AND REVISED THE 32MM BIOLOX HEAD M WITH A 32MM BIOLOX HEAD M THE SAME DAY OF PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602053 LINER: MPACT FLAT PE HC LINER Ø32/E FLAT PE HC LINER LPH MEDACTA INTERNATIONAL SA 01.32.3244HCT 1905498 07630030811913

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention