BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 9

    MDR report key: 6788499 · Received August 11, 2017

    Report

    Report Number
    1818910-2017-22685
    Event Type
    Injury
    Date Received
    August 11, 2017
    Date of Event
    July 17, 2017
    Report Date
    August 23, 2017
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    KWA
    UDI-DI
    10603295168751
    PMA / PMN Number
    K042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT STATES PATIENT EXPERIENCED A CLICKING NOISE DUE TO IMPLANT FRACTURE. DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. 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

    HOSPITAL REPORTED TO (B)(6): PATIENT BENT FORWARD TO SHAKE A LITTLE CARPET WHEN SHE EXPERIENCED A CLICKING NOISE. AFTER THIS AN INDEPENDENT MOBILIZATION WAS NO LONGER POSSIBLE. ADDITIONAL INFORMATION RECEIVED LOT NUMBER OF BROKEN STEM "2811697" AND PATIENT DETAILS, DOI, DOR, MEDICAL REPORT AND X-RAYS

    Description of Event or Problem · 1

    UPDATE AUG 23, 2017: MEDICAL RECORDS HAVE BEEN REVIEWED. MEDICAL REPORT INDICATES THAT THE PATIENT BENT OVER AND HEARD A CRACKING, SIMILAR TO WHAT IS HEARD IN LUXATION. AFTER THIS MOBILIZATION WAS NO LONGER MECHANICALLY POSSIBLE WITHOUT PAIN. THE RADIOLOGICAL DIAGNOSTICS PERFORMED SHOWED THAT THE ENDOPROSTHESIS MATERIAL INSIDE HAD BROKEN, IT WAS ESTABLISHED A REVISION OPERATION WAS INDICATED. PRE-REVISION DIAGNOSIS WAS INDICATED TO BE: BREAKAGE OF IMPLANT, I.E. , THE STEM OF THE ENDOPROSTHESIS, AND SUBCLINICAL LOOSENING OF THE ACETABULUM IN THE LEFT HIP TEP. IT IS ALSO INDICATED WITHIN THE MEDICAL REPORT THAT THE PATIENT EXPERIENCED CONTINUOUSLY RECURRING LUXATIONS SINCE (B)(6) 2015. SURGICAL INDICATION: ADMISSION WITH SPONTANEOUS IMPLANT RUPTURE OF THE ENDOPROSTHETIC STEM. NO TRAUMA. NO COMPLAINTS PRIOR TO THE BREAK SINCE THE LAST REVISION 2015. PATIENT WAS VERY SATISFIED AND HAD GOOD MOBILITY. NATIVE X-RAY OF THE ACETABULUM, HOWEVER, SHOWS FINE LYSES AND BONY REACTIONS OF THE ACETABULUM; THEREFORE, LOOSENING ALSO SUSPECTED HERE. SURGERY REPORT: THE BROKEN-OFF NECK AND HEAD PORTION OF THE ENDOPROSTHESIS STEM IS RECOVERED AND COMPLETELY REMOVED. IN THE AREA OF THE ENDOPROSTHESIS NECK ARE SOME GRINDING AND SCRATCH MARKS. IT IS POSSIBLE THERE WERE RECURRENT IMPINGEMENT SITUATIONS HERE. THERE IS ONLY A SMALL AMOUNT OF METALLOSIS IN THE JOINT. THE CUP IS MOVABLE IN ITS BONY BED AND HAS SOME GIVE. THERE IS THEREFORE CLEARLY AN IMPLANT LOOSENING, WHICH WAS ALREADY SUSPECTED IN THE EXISTING X-RAY IMAGES. DECISION TO REPLACE THE CUP WAS MADE. THERE APPEARS TO BE NO SURFACE-COVERING OSTEO-INTEGRATION. OSTEOTOMY TO OBTAIN DESIRED WINDOW WAS PERFORMED TO REMOVE THE STEM. THROUGH CHISEL WORK AND ADDITIONAL REMOVAL METHODS THE STEM IS REMOVED WITH AN INTRAOPERATIVE COMPLICATION OF MULTIPLE-FRAGMENT FRACTURE OF THE GREATER TROCHANTER MASS DURING EXPLANTATION. IT IS ALSO NOTED THAT DUE TO THE UNSTABLE MULTIPLE-FRAGMENT FRACTURE OF THE ENTIRE PROXIMAL FEMUR UP TO THE CORTICALIS WINDOW LOCATED IN THE SUBTROCHANTERIC REGION, THERE IS AN INDICATION FOR THE IMPLANTATION OF A CEMENT-FREE LONG STEM REVISION ENDOPROSTHESIS. THERE IS ALSO PLACEMENT OF TWO CERCLAGES AROUND THE CORTICALIS WINDOW. UPDATED 9-21-2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569634 CORAIL2 STD SIZE 9 HIP FEMORAL STEM/SLEEVE KWA DEPUY IRELAND 9616671 2881697 10603295168751

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention