BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 60/28

    MDR report key: 5363601 · Received January 13, 2016

    Report

    Report Number
    3005180920-2015-00373
    Event Type
    Injury
    Date Received
    January 13, 2016
    Date of Event
    December 13, 2015
    Report Date
    April 8, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2010. ON (B)(6) 2015 THE PATIENT HAD THE FIRST REVISION SURGERY (MDR 2015-00269). BATCH REVIEW PERFORMED ON 13 JANUARY 2016: LOT 152106: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 JUNE 2015. EXPIRATION DATE: 2020-04-30. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    ON 11MAR2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 14MAR2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2015 THE PATIENT HAD A SECOND REVISION SURGERY. THE SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT AND SWAPPED THE HEAD AND LINER DUE TO POSSIBLE INFECTION. THERE WAS NO INFECTION DETECTED. THERE ARE NO X-RAYS AVAILABLE. THE EXPLANTS WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21422 VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 60/28 MOBILE HIP LINER MEH MEDACTA INTERNATIONAL SA 152106

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention