BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 48/28

    MDR report key: 9178276 · Received October 11, 2019

    Report

    Report Number
    3005180920-2019-00860
    Event Type
    Injury
    Date Received
    October 11, 2019
    Date of Event
    September 12, 2019
    Report Date
    October 11, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807244
    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 17 SEPTEMBER 2019. LOT 168639: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-MAR-2017. EXPIRATION DATE: 2022-02-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. OTHER DEVICE INVOLVED: BALL HEADS: MECTACER 01.29.201 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5 LOT. 170680 (K112115). BATCH REVIEW PERFORMED ON 17 SEPTEMBER 2019. LOT 170680: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-MAY-2017. EXPIRATION DATE: 2022-05-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER ALMOST 2 YEARS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977020 LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 48/28 DOUBLE MOBILITY HC LINER MEH MEDACTA INTERNATIONAL SA 168639 07630030807244

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention