BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT OFFSET 4MM PE HC LINER Ø36/D

    MDR report key: 13058895 · Received December 22, 2021

    Report

    Report Number
    3005180920-2021-01029
    Event Type
    Injury
    Date Received
    December 22, 2021
    Date of Event
    December 7, 2021
    Report Date
    December 22, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630040731010
    PMA / PMN Number
    K183582
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 15 DECEMBER 2021: LOT 1810834: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 4-MAR-2019. EXPIRATION DATE: 2024-FEB-20 NO ANOMALIES WERE FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WIT 1 SIMILAR REPORTED EVENT. ADDITIONAL COMPONENTS INVOLVED: BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT. 2011679. LOT 2011679: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-FEB-2021. EXPIRATION DATE: 2026-FEB-10 NO ANOMALIES WERE FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT SIMILAR REPORTED EVENTS. CUP: MPACT 01.32.150DH ACETABULAR SHELL Ø50 TWO-HOLES (K132879) LOT. 1909289. LOT 1909289: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-FEB-2020. EXPIRATION DATE: 2025-FEB-02 NO ANOMALIES WERE FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT SIMILAR REPORTED EVENTS.

    Description of Event or Problem · 0

    AT 5 MONTHS AFTER THE LAST SURGERY, 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 MEDACTA CUP AND LINER TO A COMPETITOR COMPONENT AND REVISED THE MEDACTA HEAD TO A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON REVISED THE CUP TO CHANGE ITS POSITION. THE CUP WAS MALPOSITIONED, SO AFTER REPOSITIONING THE PATIENT WOULD NOT DISLOCATE AS EASILY NOW. THIS IS THE SECOND REVISION SURGERY PERFORMED DUE TO HEAD-LINED DISLOCATION FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1965722 LINER: MPACT OFFSET 4MM PE HC LINER Ø36/D HIP ACETABULAR LINER LPH MEDACTA INTERNATIONAL SA 01.32.3641HC4 1810834 07630040731010

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention