BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER 32/D

    MDR report key: 12466364 · Received September 14, 2021

    Report

    Report Number
    3005180920-2021-00740
    Event Type
    Injury
    Date Received
    September 14, 2021
    Date of Event
    August 17, 2021
    Report Date
    September 14, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030811876
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 19 AUGUST 2021: LOT 171736: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JULY-2017. EXPIRATION DATE: 2022-JULY-14. 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 IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 (K112115) LOT. 173291. BATCH REVIEW PERFORMED ON 19 AUGUST 2021. LOT 173291: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-SEPT-2017. EXPIRATION DATE: 2022-AUG-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED 3 YEARS AND 9 MONTHS AFTER THE PRIMARY SURGERY DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD, LINER, AND CUP. SURGERY COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1363240 LINER: MPACT FLAT PE HC LINER 32/D ACETABULAR PE HC LINER LPH MEDACTA INTERNATIONAL SA 01.32.3241HCT 171736 07630030811876

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention