BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø32/E

    MDR report key: 12826706 · Received November 17, 2021

    Report

    Report Number
    3005180920-2021-00882
    Event Type
    Injury
    Date Received
    November 17, 2021
    Date of Event
    October 18, 2021
    Report Date
    November 17, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030811913
    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 19 OCTOBER 2021. LOT 183102: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUL-2018. EXPIRATION DATE: 2023-JUL-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 19 OCTOBER 2021. BALL HEADS: MECTACER 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 (K112115) LOT. 180535; LOT 180535: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JUL-2018. EXPIRATION DATE: 2023-JUL-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT ((B)(4)).

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER 2 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1729938 LINER: MPACT FLAT PE HC LINER Ø32/E HIP FLAT LINER LPH MEDACTA INTERNATIONAL SA 01.32.3244HCT 183102 07630030811913

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention