BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER 28 / C

    MDR report key: 11618156 · Received April 6, 2021

    Report

    Report Number
    3005180920-2021-00265
    Event Type
    Injury
    Date Received
    April 6, 2021
    Date of Event
    March 8, 2021
    Report Date
    April 6, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807091
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 17 MARCH 2021: LOT 156954: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-APR-2016. EXPIRATION DATE: 2021-03-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 1-JAN-2017. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: COCR 01.25.012 COCR BALL HEAD 12/14 Ø 28 SIZE M 0 (K072857) LOT. 162046. BATCH REVIEW PERFORMED ON 17 MARCH 2021: LOT 162046: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MAY-2016. EXPIRATION DATE: 2021-04-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 1-JAN-2017. ADDITIONAL IMPLANT INVOLVED: CUP: VERSAFITCUP CC TRIO 01.26.45.1148 ACETABULAR SHELL CC TRIO NO-HOLE Ø 48 (K122911) LOT. 161601. BATCH REVIEW PERFORMED ON 06 APRIL 2021: LOT 161601: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-JUN-2016. EXPIRATION DATE: 2021-06-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 1-JAN-2017. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: ACETABULAR COMPONENT REVISION PERFORMED 4.5 YEARS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY IN A (B)(6) YEAR OLD WOMAN. ALTHOUGH NO LATERAL PROJECTION IS AVAILABLE, IN THE RADIOGRAPHIC IMAGE PROVIDED THE POSITION OF THE ACETABULAR CUP APPEARS TO BE INADEQUATE. WE CANNOT TELL IF THIS IS THE RESULT OF POST-SURGERY MIGRATION OR THE SURGEON'S CHOICE: IN THE LATTER CASE, NO EXPLANATION FOR THIS DECISION WAS SUPPLIED. IN THESE CONDITIONS, IT IS VERY LIKELY THAT PART OF THE FEMORAL STEM MAY IMPINGE WITH THE ACETABULAR RIM AND THEREFORE DISLOCATION OCCURS. THE CAUSE OF DISLOCATION SHOULD BE DEFINED AS CUP POSITION. THE CAUSE FOR SUCH CUP POSITION IS UNKNOWN.

    Description of Event or Problem · 1

    REVISION SURGERY 4 YEARS AND 6 MONTHS AFTER PRIMARY FOR HIP ANTERIOR LUXATION. THE SURGEON REVISED SUCCESSFULLY THE CUP, INLAY AND HEAD WITH DOUBLE MOBILITY VERSACEM AND BIOLOX OPTION 28 XL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519955 LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER 28 / C ACETABULAR PE HC LINER LZO MEDACTA INTERNATIONAL SA 01.26.2839HCT 156954 07630030807091

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention