BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMET

    MDR report key: 4652660 · Received March 24, 2015

    Report

    Report Number
    9614209-2015-00014
    Event Type
    Injury
    Date Received
    March 24, 2015
    Date of Event
    May 5, 2014
    Report Date
    August 9, 2016
    Manufacturer
    CORIN MEDICAL
    Product Code
    NXT
    PMA / PMN Number
    P050016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL REPORT. EXPLANTED DEVICES, PATIENT NOTES, PATHOLOGY REPORTS, POST PRIMARY AND PRE-REVISION X-RAYS AND REASON FOR REVISION HAVE BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION. DEVICE MANUFACTURING RECORDS TO BE REVIEWED ONCE THE LOT CODES ARE CONFIRMED. PLEASE NOTE: THE PRODUCT COMBINATION (HEAD, CUP) REPORTED IN THIS MDR IS NOT CLEARED FOR USE AS COMPATIBLE COMPONENTS IN THE USA. THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA. HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA.

    Additional Manufacturer Narrative · 1

    (B)(4) FINAL REPORT. EXPLANTED DEVICES, PATIENT NOTES, PATHOLOGY REPORTS, POST PRIMARY AND PRE-REVISION X-RAYS AND THE REASON FOR REVISION WERE REQUESTED IN ORDER TO PROGRESS WITH THIS INVESTIGATION. HOWEVER, NOT ALL OF THESE WERE PROVIDED, THEREFORE, THERE WAS LIMITED INFORMATION AVAILABLE FOR THIS INVESTIGATION. THE RELEVANT DEVICE MANUFACTURING RECORDS HAVE BEEN RETRIEVED AND REVIEWED AND IT WAS FOUND THAT THE PARTS ASSOCIATED WITH THIS REPORT CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION WHEN MANUFACTURED. EXPLANT EXAMINATION AT CORIN CONCLUDED THAT THERE WAS NO INDICATION THAT THE BEARING WAS ASSOCIATED WITH THE REPORTED EVENT. SIGNS OF OSSEOINTEGRATION WERE OBSERVED ON THE BONE INTERFACE SURFACE. THE CORIN CORMET AND OPTIMOM IMPLANTS WERE COUPLED WITH NON-CORIN MODULAR NECK, FEMORAL STEM AND SLEEVE. BASED ON THIS CORIN NOW CONSIDERS THIS CASE CLOSED BUT WILL RE-OPEN SHOULD ANY NEW INFORMATION COME TO LIGHT. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN ADVERSE EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA.

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL REPORT. EXPLANTED DEVICES, PATIENT NOTES, PATHOLOGY REPORTS, POST PRIMARY AND PRE-REVISION X-RAYS AND THE REASON FOR REVISION WERE REQUESTED IN ORDER TO PROGRESS WITH THIS INVESTIGATION. HOWEVER, NOT ALL OF THESE WERE PROVIDED, THEREFORE, THERE WAS LIMITED INFORMATION AVAILABLE FOR THIS INVESTIGATION. THE RELEVANT DEVICE MANUFACTURING RECORDS HAVE BEEN RETRIEVED AND REVIEWED AND IT WAS FOUND THAT THE PARTS ASSOCIATED WITH THIS REPORT CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION WHEN MANUFACTURED. EXPLANT EXAMINATION AT CORIN CONCLUDED THAT THERE WAS NO INDICATION THAT THE BEARING WAS ASSOCIATED WITH THE REPORTED EVENT. SIGNS OF OSSEOINTEGRATION WERE OBSERVED ON THE BONE INTERFACE SURFACE. THE CORIN CORMET AND OPTIMOM IMPLANTS WERE COUPLED WITH NON-CORIN MODULAR NECK, FEMORAL STEM AND SLEEVE. BASED ON THIS CORIN NOW CONSIDERS THIS CASE CLOSED BUT WILL RE-OPEN SHOULD ANY NEW INFORMATION COME TO LIGHT. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN ADVERSE EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA.

    Description of Event or Problem · 1

    REVISION OF CORMET CUP.

    Description of Event or Problem · 1

    REVISION OF A CORMET CUP AFTER IMPLANTATION FOR 8 YEARS AND 7 MONTHS

    Description of Event or Problem · 1

    REVISION OF A CORMET CUP AFTER IMPLANTATION FOR 8 YEARS AND 7 MONTHS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197761 CORMET HIP RESURFACING PROSTHESIS NXT CORIN MEDICAL 179.246B INBD

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R