BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL STEM K10S HAC

    MDR report key: 3510428 · Received December 10, 2013

    Report

    Report Number
    1818910-2013-35580
    Event Type
    Injury
    Date Received
    December 10, 2013
    Report Date
    December 9, 2013
    Manufacturer
    3003895575 DEPUY FRANCE
    Product Code
    LZO
    PMA / PMN Number
    PK953111
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE REPORT. VISUAL ANALYSIS OF THE RETURNED PRODUCT SHOWS A PARTIAL DISAPPEARANCE OF HYDROXYAPATITE WHICH IS NORMAL BECAUSE THE BODY NATURALLY ABSORBS AND INTEGRATES THE COATING IN THE MONTHS FOLLOWING IMPLANTATION. IT IS NOT NOTED OSTEO-INTEGRATION ON THE STEM. THE PRODUCT WAS CHECKED DIMENSIONALLY AT VARIOUS PLACES AND FOUND TO BE IN CONFORMITY WITH ITS DEFINITION. THE DHR ANALYSIS OF THE BATCH RETURNED SHOWS AN INITIAL CONFORMANCE OF THIS PRODUCT WITH REGARDS TO ITS SPECIFICATION. FOR THIS BATCH, THERE WAS NO DEVIATION OR FAILURE INVESTIGATION REPORT. THE ANALYSIS SHOWED THAT NO METALLURGICAL DEFECT LIKE BULKY INCLUSION, COARSE MICROSTRUCTURE HAS BEEN OBSERVED NEAR THE INITIATION AREA. THAT INDICATES THE FAILURE IS NOT DUE TO A BAD RAW MATERIAL OR A PROBLEM DURING THE MANUFACTURING OF THIS STEM (MECHANICAL DAMAGE). THE PROBABLE HYPOTHESIS TO EXPLAIN THE FAILURE IS A LOOSENING OF THE PROXIMAL PART OF THE STEM CONSECUTIVE OF NON OPTIMAL BONY RECONSTRUCTIONS WHICH HAVE LEAD TO AN IMPORTANT FLEXION IN AN AREA WHICH NORMALLY IS NOT STRESSED IN FLEXION. REVIEW OF PROVIDED PATIENT X-RAYS CONFIRMS FRACTURE IN VIVO AND LOOSENING. THE CUP APPEARS TO BE POSITIONED IN RETRO-VERSION, AS OPPOSED TO ANTI-VERSION AS RECOMMENDED BY THE SURGICAL TECHNIQUE. THE INFLUENCE OF THIS ON THE EVENTUAL FAILURE IS UNKNOWN. WHILST THE DEFINITIVE ROOT CAUSE IS UNKNOWN, THE FOLLOWING FACTORS ARE CONSIDERED TO HAVE CONTRIBUTED TO THE FAILURE OF THE STEM. THE CHALLENGING FEMORAL ANATOMY (DORR TYPE A). THE CORIAL AMT SURGICAL TECHNIQUE NOW RECOMMENDS DISTAL REAMING FOR THIS TYPE OF PATIENT ANATOMY. THE STEM WAS UNDERSIZED FOR THE METAPHYSIS (LIKELY DUE TO THE NARROW CANAL). THE PATIENTS WEIGHT (WHILST IT REDUCED) IS HIGH AND WILL HAVE CHALLENGED THE STEM IN THE ADVERSE MECHANICAL CONDITIONS AS A RESULT OF THE LACK OF PROXIMAL SUPPORT FOR THE STEM. THE SURGICAL NOTES ATTACHED TO THE COMPLAINT HAVE BEEN REVIEWED. THESE NOTES TO NOT HELP TO DETERMINE THE ROOT CAUSE OF THE FAILURE. BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE COMPLAINT WAS UNDETERMINED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CORAIL DISTAL STEM BREAKAGE AFTER STEM LOOSENING.

    Description of Event or Problem · 1

    UPDATE DEC 9, 2013: LOT NUMBER RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641192 CORAIL STEM K10S HAC FEMORAL HIP STEM LZO 3003895575 DEPUY FRANCE 1244679

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention