BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK HIP FEMORAL STEM CORAIL

    MDR report key: 10940015 · Received December 3, 2020

    Report

    Report Number
    1818910-2020-26061
    Event Type
    Malfunction
    Date Received
    December 3, 2020
    Date of Event
    April 28, 2019
    Report Date
    November 22, 2020
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    KWY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT :THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). WHERE THE LOT CODE WAS PROVIDED, A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED. CORRECTED: D3, G1.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    LITERATURE ARTICLE ENTITLED ¿LONG-TERM MIGRATION CHARACTERISTICS OF THE CORAIL HYDROXYAPATITE-COATED FEMORAL STEM: A 14-YEAR RADIOSTEREOMETRIC ANALYSIS FOLLOW-UP STUDY¿ BY OWAIN CRITCHLEY, ET AL, PUBLISHED BY THE ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY (2020), VOL. 140, PP. 121-127, WAS REVIEWED. THE PURPOSE OF THIS STUDY WAS TO MEASURE THE AMOUNT OF SUBSIDENCE FOR A CORAIL CEMENTLESS STEM IMPLANTED IN PATIENTS WITH OSTEOPOROSIS OVER 14 YEARS USING PROGRESSIVE RADIOSTEREOMETRIC IMAGING PERFORMED AT 6 MONTHS, 1 YEAR, 2 YEARS, 6 YEARS, AND 14 YEARS. THE MEASUREMENTS WERE TAKEN USING MARKERS IMPLANTED AT PRIMARY SURGERY. THIS COMPLAINT WILL CAPTURE THE RESULTS FOR 23 PATIENTS IDENTIFIED IN TABLE 1 ON PAGE 124. NO IMPLANTS IN THE STUDY COHORT HAVE BEEN REVISED. ONE RADIOGRAPHIC IMAGE IS AVAILABLE IN FIG 2 ON PAGE 123. RESULTS: PATIENT 1: TOTAL OF 18.118 MM SUBSIDENCE IDENTIFIED ON PROGRESSIVE IMAGING STUDIES OVER 14 YRS. NO PATIENT CONSEQUENCES OR REVISIONS. PATIENT 3: TOTAL OF 3.954 MM SUBSIDENCE IDENTIFIED ON PROGRESSIVE IMAGING STUDIES OVER 6 YRS. NO PATIENT CONSEQUENCES OR REVISIONS. THE FOLLOW-UP WAS DISCONTINUED DUE TO PATIENT AGE AND INFIRMITY. PATIENT 4: TOTAL OF 0.168 MM SUBSIDENCE IDENTIFIED ON PROGRESSIVE IMAGING STUDIES OVER 6YRS. NO PATIENT CONSEQUENCES OR REVISIONS. THE PATIENT DIED AFTER 6-YEAR FOLLOW-UP FOR CAUSES UNRELATED TO THE THA OR THE SURGICAL PROCEDURE. PATIENT 6: TOTAL OF 1.443 MM SUBSIDENCE IDENTIFIED ON PROGRESSIVE IMAGING STUDIES OVER 14 YRS. NO PATIENT CONSEQUENCES OR REVISIONS. PATIENT 7: TOTAL OF 0.407 MM SUBSIDENCE IDENTIFIED ON PROGRESSIVE IMAGING STUDIES OVER 14 YRS. NO PATIENT CONSEQUENCES OR REVISIONS. PATIENT 8: TOTAL OF 0.833 MM SUBSIDENCE IDENTIFIED ON PROGRESSIVE IMAGING STUDIES OVER 14 YRS. NO PATIENT CONSEQUENCES OR REVISIONS. PATIENT 9: TOTAL OF 3.087 MM SUBSIDENCE IDENTIFIED ON PROGRESSIVE IMAGING STUDIES OVER 6YRS. NO PATIENT CONSEQUENCES OR REVISIONS. THE PATIENT DIED AFTER 6-YEAR FOLLOW-UP FOR CAUSES UNRELATED TO THE THA OR THE SURGICAL PROCEDURE. PATIENT 10: TOTAL OF 0.518 MM SUBSIDENCE IDENTIFIED ON PROGRESSIVE IMAGING STUDIES OVER 14 YRS. NO PATIENT CONSEQUENCES OR REVISIONS. PATIENT 11: TOTAL OF 0.420 MM SUBSIDENCE IDENTIFIED ON PROGRESSIVE IMAGING STUDIES OVER 14 YRS. NO PATIENT CONSEQUENCES OR REVISIONS. PATIENT 14: TOTAL OF 0.486 MM SUBSIDENCE IDENTIFIED ON PROGRESSIVE IMAGING STUDIES OVER 14 YRS. NO PATIENT CONSEQUENCES OR REVISIONS. PATIENT 15: TOTAL OF 0.316 MM SUBSIDENCE IDENTIFIED ON PROGRESSIVE IMAGING STUDIES OVER 6 YRS. NO PATIENT CONSEQUENCES OR REVISIONS. THE PATIENT DIED AFTER 6-YEAR FOLLOW-UP FOR CAUSES UNRELATED TO THE THA OR THE SURGICAL PROCEDURE. PATIENT 16: TOTAL OF 0.373 MM SUBSIDENCE IDENTIFIED ON PROGRESSIVE IMAGING STUDIES OVER 14 YRS. NO PATIENT CONSEQUENCES OR REVISIONS. PATIENT 17: TOTAL OF 0.290 MM SUBSIDENCE IDENTIFIED ON PROGRESSIVE IMAGING STUDIES OVER 6 YRS. NO PATIENT CONSEQUENCES OR REVISIONS. THE PATIENT DIED AFTER 6-YEAR FOLLOW-UP FOR CAUSES UNRELATED TO THE THA OR SURGICAL PROCEDURE. PATIENT 19: THIS PATIENT WAS EXCLUDED FROM THE STUDY DUE TO AN INTRAOPERATIVE FEMORAL FRACTURE SUSTAINED DURING SEATING OF THE STEM. PATIENT 20: TOTAL OF 3.412 MM SUBSIDENCE IDENTIFIED ON PROGRESSIVE IMAGING STUDIES OVER 6 YRS. NO PATIENT CONSEQUENCES OR REVISIONS. THE PATIENT DIED AFTER 6-YEAR FOLLOW-UP FOR CAUSES UNRELATED TO THE THA OR THE SURGICAL PROCEDURE. PATIENT 21: TOTAL OF 8.1 MM SUBSIDENCE IDENTIFIED ON PROGRESSIVE IMAGING STUDIES OVER 14 YRS. NO PATIENT CONSEQUENCES OR REVISIONS. PATIENT 22: TOTAL OF 7.126 MM SUBSIDENCE IDENTIFIED ON PROGRESSIVE IMAGING STUDIES OVER 6 YRS. NO PATIENT CONSEQUENCES OR REVISIONS. THE FOLLOW-UP WAS DISCONTINUED DUE TO PATIENT AGE AND INFIRMITY. PATIENT 23: TOTAL OF 5.025 MM SUBSIDENCE IDENTIFIED ON PROGRESSIVE IMAGING STUDIES OVER 6 YRS. NO PATIENT CONSEQUENCES OR REVISIONS. THE PATIENT DIED AFTER 6-YEAR FOLLOW-UP FOR CAUSES UNRELATED TO THE THA OR THE SURGICAL PROCEDURE. PATIENT 25: TOTAL OF 1.276 MM SUBSIDENCE IDENTIFIED ON PROGRESSIVE IMAGING STUDIES OVER 6 YRS. NO PATIENT CONSEQUENCES OR REVISIONS. THE PATIENT DIED AFTER 6-YEAR FOLLOW-UP FOR CAUSES UNRELATED TO THE THA OR THE SURGICAL PROCEDURE. PATIENT 26: TOTAL OF 1.047 MM SUBSIDENCE IDENTIFIED ON PROGRESSIVE IMAGING STUDIES OVER 14 YRS. NO PATIENT CONSEQUENCES OR REVISIONS. PATIENT 27: TOTAL OF 7.321 MM SUBSIDENCE IDENTIFIED ON PROGRESSIVE IMAGING STUDIES OVER 6 YRS. NO PATIENT CONSEQUENCES OR REVISIONS. THE FOLLOW-UP WAS DISCONTINUED DUE TO PATIENT AGE AND INFIRMITY. PATIENT 28: TOTAL OF 0.214 MM SUBSIDENCE IDENTIFIED ON PROGRESSIVE IMAGING STUDIES OVER 6 YRS. NO PATIENT CONSEQUENCES OR REVISIONS. THE PATIENT DIED AFTER 6-YEAR FOLLOW-UP FOR CAUSES UNRELATED TO THE THA OR THE SURGICAL PROCEDURE. PATIENT 29: TOTAL OF 3.974MM SUBSIDENCE IDENTIFIED ON PROGRESSIVE IMAGING STUDIES OVER 14 YRS. NO PATIENT CONSEQUENCES OR REVISIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1408124 UNK HIP FEMORAL STEM CORAIL FEMORAL STEM KWY DEPUY FRANCE SAS - 3003895575

    Patients

    Seq Age Sex Outcome Treatment
    1