BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8577873 · Received May 3, 2019

    Report

    Report Number
    3005180920-2019-00340
    Event Type
    Injury
    Date Received
    May 3, 2019
    Date of Event
    April 3, 2019
    Report Date
    June 26, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802072
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY THE R&D PROJECT MANAGER ON THE STEM RECEIVED: FEMORAL STEM SHOWS HA LAYER STILL INTACT ON THE PROXIMAL PART OF THE STEM. SIGNS DUE TO REVISION ON THE NECK. IN THE EVENT DESCRIPTION HAS BEEN ADDED THAT ALSO THE HEAD HAS BEEN REVISED.

    Description of Event or Problem · 0

    ABOUT 2 YEARS AND 9 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT HIP FOR A SUSPECTED INFECTION. THE STEM COME OUT EASY FROM FEMUR DURING THE REVISION. THE STEM AND THE HEAD WERE REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 29 APR 2019: LOT 156215: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JAN-2016. EXPIRATION DATE: 2021-01-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. OTHER DEVICES WERE INVOLVED IN THE EVENT: BALL HEADS: MECTACER 01.29.214 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE L + 4 LOT. 150463 (K112115): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-APR-2015. EXPIRATION DATE: 2020-02-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CUP: MPACT 01.32.158DH ACETABULAR SHELL Ø58 TWO-HOLES LOT. 162911 (K132879): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JUN-2016. EXPIRATION DATE: 2021-06-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THIS SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. LINER: MPACT 01.32.4048HCT FLAT PE HC LINER Ø40/F LOT. 157212 (K122641): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-FEB-2016. EXPIRATION DATE: 2021-01-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: FEMORAL COMPONENT REVISION SURGERY OCCURRED 2 YEARS AND 7 MONTHS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY IN A HEAVY (B)(6) MAN. RADIOGRAPHIC IMAGES PROVIDED SHOW THE PRESENCE OF OSTEOLYTIC ZONES AROUND THE STEM AND BONE QUALITY ALTERATIONS IN THE GREATER TROCHANTER REGION. ACCORDING TO THE REPORT AND THE RADIOLOGICAL FINDINGS, AN INFECTION COULD BE A POSSIBLE CAUSE OF THIS EVENT. HOWEVER, ON THE BASIS OF THE INFORMATION RECEIVED, THIS HYPOTHESIS CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    ABOUT 2 YEARS AND 9 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT HIP FOR A SUSPECTED INFECTION. THE STEM COME OUT EASY FROM FEMUR DURING THE REVISION. THE STEM WAS REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370002 STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 6 HIP CEMENTLESS STEM JDI MEDACTA INTERNATIONAL SA 156215 07630030802072

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention