BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 48/28

    MDR report key: 10546258 · Received September 17, 2020

    Report

    Report Number
    3005180920-2020-00614
    Event Type
    Injury
    Date Received
    September 17, 2020
    Date of Event
    August 19, 2020
    Report Date
    September 17, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807244
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 26 AUGUST 2020: LOT 2000166: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-APR-2020. EXPIRATION DATE: 2025-03-30. 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. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 26 AUGUST 2020. BALL HEADS: MECTACER 01.29.240A SLEEVE SIZE S (K131518) LOT. 184406. LOT 184406: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-SEP-2018. EXPIRATION DATE: 2023-09-02. 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. BALL HEADS: MECTACER 01.29.230H HEAD BIOLOX OPTION Ø 28 (K131518) LOT. 19C0059. LOT 19C0059: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-DEC-2019. EXPIRATION DATE: 2024-11-30. 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 HAD A PRIMARY HIP SURGERY ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM. HEAD, STEM, AND LINER WERE REVISED. ON (B)(6) 2020, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. WASHOUT WAS PERFORMED, HEAD AND LINER WERE REVISED. PRESENTLY, ON (B)(6) 2020, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD, SLEEVE AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009657 LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 48/28 DOUBLE MOBILITY HC LINER MEH MEDACTA INTERNATIONAL SA 01.26.2848MHC 2000166 07630030807244

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention