BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 56/28

    MDR report key: 8155028 · Received December 12, 2018

    Report

    Report Number
    3005180920-2018-00985
    Event Type
    Injury
    Date Received
    December 12, 2018
    Date of Event
    November 12, 2018
    Report Date
    December 12, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807411
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 12 DECEMBER 2018. LOT 167576: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 FEBRUARY 2017. EXPIRATION DATE: 2022-01-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED IN THE ISSUE: CUP: VERSAFITCUP 01.26.56MB ACETABULAR SHELL Ø 56 (K083116), LOT 176619: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 FEBRUARY 2018. EXPIRATION DATE: 2023-02-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: EARLY DISLOCATION OF A DUAL MOBILITY CUP IN PRIMARY CEMENTLESS THA. THIS EVENT MAY HAVE BEEN CAUSED BY A SUBOPTIMAL POSITION OF THE ACETABULAR CUP OR BY INSUFFICIENT TENSION OF THE SOFT TISSUES, IT IS NOT A DEVICE PROBLEM.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO A DISLOCATION OF THE LINER FROM THE CUP 3 MONTHS AFTER PRIMARY SURGERY. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON USED A POSTERIOR APPROACH IN PRIMARY SURGERY. A BONE FRACTURE, VISIBLE ON THE X-RAYS, OCCURRED MUCH EARLIER IN THE PATIENT'S LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996923 VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 56/28 HIP DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 167576 07630030807411

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention