BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 4

    MDR report key: 8711639 · Received June 19, 2019

    Report

    Report Number
    3005180920-2019-00495
    Event Type
    Injury
    Date Received
    June 19, 2019
    Date of Event
    May 23, 2019
    Report Date
    July 23, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030802744
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: FEMORAL STEM: NECK WITH DEEP SCRATCHES, UNKNOWN REASON, NO SIGN ON THE ACETABULAR SHELL RIM THAT SUGGEST REPEATED IMPINGEMENT EVENTS. STEM WITH BONE RESIDUALS AND HA LAYER STILL INTACT. DEEP SCRATCHES ARE VISIBLE. ACETABULAR CUP: SCRATCHES OF UNKNOWN REASON ON THE INTERNAL SURFACE. OUTER REGION SHOWS BONE RESIDUALS. DM PE LINER: HIGHLY SCRATCHED ON THE EXTERNAL EQUATORIAL EDGE. FEMORAL HEAD: NO PARTICULAR SIGNS. IT IS NOT POSSIBLE TO DETERMINE A FAILURE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 JUNE 2019: LOT 170887: (B)(6) ITEMS MANUFACTURED AND RELEASED ON 23 AUGUST 2017. EXPIRATION DATE: 2022-07-20. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ANOTHER DEVICE WAS INVOLVED IN THE COMPLAINT. BATCH REVIEW PERFORMED ON 18 JUNE 2019: CUP: VERSAFITCUP 01.26.52MB ACETABULAR SHELL Ø 52, LOT. 177261 (K083116): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 FEBRUARY 2018. EXPIRATION DATE: 2023-02-20. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ON MAY 22 WE WERE INFORMED ABOUT A REVISION SURGERY PERFORMED ON MAY 23. THE PATIENT HAD HIP PAIN AND WAS INSTABLE. THE PATIENT WAS 1.5CM SHORT ON THE OPERATED SIDE. ONCE INSIDE THE SURGEON NOTICED A LARGE PSEUDOTUMOR AND NUMEROUS SIMILAR MEMBRANES. THE PRIMARY DIAGNOSIS WAS LOOSENING OF THE STEM AS IT APPEARS TO HAVE SUBSIDED CAUSING THE SECONDARY DIAGNOSIS OF INSTABILITY. SO ABOUT 7 MONTHS AFTER PRIMARY THE SURGEON REMOVED THE STEM AND DUE TO THE PSEUDOTUMOR AND REACTION IN THE JOINT HE DECIDED TO ALSO REMOVE THE CUP. THE SURGEON SUGGESTED THAT THERE IS EVIDENCE OF IMPINGEMENT OF THE NECK AND THE SIDE OF THE CUP. ALL MEDACTA COMPONENTS WERE REMOVED AND OTHER COMPANY IMPLANTS WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504033 STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 4 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 170887 07630030802744

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention