BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER 52/28

    MDR report key: 12142141 · Received July 9, 2021

    Report

    Report Number
    3005180920-2021-00577
    Event Type
    Injury
    Date Received
    July 9, 2021
    Date of Event
    June 17, 2021
    Report Date
    July 9, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807336
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 01 JULY 2021: LOT 090085: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-APR-2009. EXPIRATION DATE: 2014-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 1-JAN-2017. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 38.39.7175.245.00 BIOLOX FORTE CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5 (USA) (K073337) LOT. 082881. BATCH REVIEW PERFORMED ON 01 JULY 2021: LOT 082881: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-OCT-2008. EXPIRATION DATE: 2013-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 1-1-2017.

    Description of Event or Problem · 1

    11 YEARS AND 11 MONTHS AFTER PRIMARY THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER AND ADDED A SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041584 LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER 52/28 DOUBLE MOBILITY ACETABULAR LINER MEH MEDACTA INTERNATIONAL SA 01.26.2852M 090085 07630030807336

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention