BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 6

    MDR report key: 9829930 · Received March 13, 2020

    Report

    Report Number
    3005180920-2020-00155
    Event Type
    Injury
    Date Received
    March 13, 2020
    Date of Event
    February 14, 2020
    Report Date
    July 21, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802072
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION. STEM NECK WITH SCRATCHES DUE TO REVISION SURGERY. SIGNS OF OSSEOINTEGRATION AND RESIDUAL HA AS WELL. ACETABULAR SHELL AND LINER WITH SIGNS OF EXTRACTION, SHELL WITH RESIDUAL HA AND SIGNS OF OSSEOINTEGRATION AS WELL. FEMORAL HEAD WITH SIGNS OF EXTRACTION. IT IS NOT POSSIBLE TO DETERMINE AN IMPLANT DESIGN RELATED FAILURE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 26 FEBRUARY 2020: LOT 181759: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-JUN-2018. EXPIRATION DATE: 2023-05-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENTS. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.208 BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE S - 4 (K112115) LOT. 1903859. BATCH REVIEW PERFORMED ON 26 FEBRUARY 2020: LOT 1903859: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JULY-2019. EXPIRATION DATE: 2024-07-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENTS. ADDITIONAL IMPLANT INVOLVED: CUP: VERSAFITCUP CC TRIO 01.26.45.1152 ACETABULAR SHELL CC TRIO NO-HOLE 52 (K122911) LOT. 1904412. BATCH REVIEW PERFORMED ON 26 FEBRUARY 2020: LOT 1904412: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUL-2018. EXPIRATION DATE: 2024-07-07. 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. ADDITIONAL IMPLANT INVOLVED: LINER: MECTACER 01.29.413 CERAMIC LINER 36 / E LOT. 1903875 - NOT DISTRIBUTED IN US. BATCH REVIEW PERFORMED ON 26 FEBRUARY 2020: LOT 1903875: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUL-2019. EXPIRATION DATE: 2024-07-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENTS. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER EARLY INFECTION IN CEMENTLESS THA, 2 MONTHS AFTER PRIMARY OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING THA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES.

    Description of Event or Problem · 1

    REVISION SURGERY ABOUT 3 MONTHS AFTER PRIMARY FOR INFECTION. THE PATIENT CAME BACK WITH AN ABSCESS ON THE ANTERIOR PART OF THE THIGH AND AN EPIDERMAL GERM WHICH HAVE LED TO TWO PUNCTURES. ALL HIP HARDWARE REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294523 STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 6 CEMENTLESS HIP STEM JDI MEDACTA INTERNATIONAL SA 01.12.026 181759 07630030802072

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention