BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP ACETABULAR SHELL Ø56

    MDR report key: 16814939 · Received April 26, 2023

    Report

    Report Number
    3005180920-2023-00316
    Event Type
    Injury
    Date Received
    April 26, 2023
    Date of Event
    March 30, 2023
    Report Date
    June 7, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030808173
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER FROM THE RECEIVED PARTS, NO PARTICULAR SIGNS RELATED TO THE EVENT WERE NOTICED; THE LINER WAS SIGNED ON ITS SURFACE, PROBABLY OCCURRED DURING THE REVISION, AND THE CERAMIC HEAD DID NOT SHOW ANY PARTICULAR SIGN, EXCEPT FOR THE INNER SIGNS DUE TO THE COUPLING WITH THE STEM. FROM THE RECEIVED PARTS AND INFORMATION IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT. NOTE: THE ACETABULAR SHELL WAS NOT SENT BACK FOR ANALYSIS, THE SCRUB TECH MADE ONLY THE LINER AND HEAD AVAILABLE TO THE SALES REP .

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 11-APR-2023: LOT 090245: 26 ITEMS MANUFACTURED AND RELEASED ON 06-MAY-2009. EXPIRATION DATE: 2014-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED BATCH REVIEW PERFORMED ON 11-APR-2023 LINER: VERSAFITCUP DM 01.26.2856M DOUBLE MOBILITY LINER Ø 56/28 (K083116) LOT 090257: 36 ITEMS MANUFACTURED AND RELEASED ON 31-MAG-2009. EXPIRATION DATE: 2014-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR: REVISION 13 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY DUE TO A FRACTURED ACETABULUM. THE PATIENT CAME IN REPORTING PAIN DUE TO A FRACTURED ACETABULUM AND THE CAUSE IS UNKNOWN. WITH THE INFORMATION AT HAND THE REASON OF THIS FAILURE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    AT ABOUT 13 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A FRACTURED ACETABULUM AND THE CAUSE IS UNKNOWN. THE SURGEON PLATED THE FRACTURE, REVISED THE MEDACTA CUP AND LINER WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668118 VERSAFITCUP ACETABULAR SHELL Ø56 HIP CEMENTLESS SHELL MEH MEDACTA INTERNATIONAL SA 01.26.56MB 090245 07630030808173

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Unknown Required Intervention