BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 NON COL HO SIZE 13

    MDR report key: 4407666 · Received January 12, 2015

    Report

    Report Number
    1818910-2015-10737
    Event Type
    Injury
    Date Received
    January 12, 2015
    Date of Event
    December 16, 2014
    Report Date
    December 16, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED TO THE COMPLAINT WERE NOT RETURNED FOR ANALYSIS.THE DHR ANALYSIS PERFORMED ON THE AFFECTED BATCH 5120026 DID NOT REVEAL ANY ANOMALIES THAT COULD BE RELATED TO THE ISSUE REPORTED ON THE COMPLAINT. A COMPLAINT SEARCH INTO THE COMPLAINTS DATABASE WAS PERFORMED, NO OTHER SIMILAR COMPLAINT WAS REPORTED IN ASSOCIATION TO BATCH NUMBER 5120026DEPUY 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

    DTHIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETEDIF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

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

    Description of Event or Problem · 1

    HIP REVISION SURGERY PERFORMED ON (B)(6) 2014 BY SURGEON AT (B)(6). THIS PATIENT REQUIRED A REVISION AS THE NECK OF THE CORAIL STEM INSITUE HAD FRACTURED.THERE IS NO REPORTED EVENT OF TRAUMA TO CAUSE THIS FRACTURE.PRIMARY TOTAL HIP REPLACEMENT WAS PERFORMED BY SURGEON AT (B)(6) ON (B)(6) 2013. DOB (B)(6). NO HEIGHT NOTED BUT PATIENT LOOKED TALL. THE SURGEON DESCRIBED THE PATIENT AS BEING VERY FIT AND HEALTHY. OCCUPATION STATUS IS UNKNOWN.EXPLANTS WILL BE FORWARDED TO (B)(6) STAFF. PRE-REVISION X-RAY AND PHOTOS OF EXPLANTED PROSTHESIS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26489 CORAIL2 NON COL HO SIZE 13 HIP FEMORAL STEM/SLEEVE KWA DEPUY INTERNATIONAL LTD. 8010379 5120026

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention