BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMET

    MDR report key: 7968624 · Received October 16, 2018

    Report

    Report Number
    9614209-2018-00074
    Event Type
    Injury
    Date Received
    October 16, 2018
    Date of Event
    August 17, 2018
    Report Date
    March 11, 2020
    Manufacturer
    CORIN GROUP
    Product Code
    NXT
    PMA / PMN Number
    P050016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). POST PRIMARY AND PRE REVISION X-RAYS, OPERATIVE NOTES, PATIENT AGE AND ACTIVITY LEVEL, PATIENT MEDICAL HISTORY AND THE RETURN OF THE EXPLANTED DEVICES WAS REQUESTED IN ORDER TO PROGRESS WITH THIS INVESTIGATION, HOWEVER, IT HAS BEEN CONFIRMED THAT NO FURTHER INFORMATION CAN BE PROVIDED FOR THIS CASE AND THAT THE EXPLANTS HAD BEEN DISCARDED BY THE HOSPITAL. THEREFORE, THERE WAS ONLY VERY LIMITED INFORMATION AVAILABLE FOR THE INVESTIGATION. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS HAVE BEEN IDENTIFIED AND REVIEWED. ALL PARTS ASSOCIATED WITH THESE RECORDS CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION AT THE TIME OF MANUFACTURE. BASED ON THE INFORMATION PROVIDED, NO FURTHER INVESTIGATION CAN BE CONDUCTED AND THUS CORIN NOW CONSIDER THIS CASE CLOSED. HOWEVER, SHOULD ANY ADDITIONAL INFORMATION BE PROVIDED THEN THIS CASE MAY BE RE-OPENED FOR FURTHER INVESTIGATION. 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 · 0

    PER -1512 FINAL REPORT: X-RAYS AND PATIENT OUTCOME WAS REQUESTED IN ORDER TO PROGRESS WITH THIS INVESTIGATION, HOWEVER, THIS INFORMATION WAS NOT AVAILABLE AND THUS THE INVESTIGATION WAS LIMITED. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS HAVE BEEN IDENTIFIED AND REVIEWED. ALL PARTS ASSOCIATED WITH THESE RECORDS CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION AT THE TIME OF MANUFACTURE. EXAMINATION OF THE RETURNED EXPLANTS DID NOT PRESENT ANY OBVIOUS FAILURE MODES OR ABNORMAL DEVICE CHARACTERISTICS. BOTH DEVICES EXHIBITED SURFACE CHARACTERISTICS EXPECTED OF AN IMPLANT WHICH HAD BEEN IN USE FOR APPROXIMATELY 12 YEARS AND THE ROOT CAUSE OF THE REPORTED PAIN COULD NOT BE IDENTIFIED. THE CORIN DEVICES WERE COUPLED WITH A TAPER CONVERSION SLEEVE (MANUFACTURER UNKNOWN) WHICH HAD EVIDENCE OF CORROSION. BASED ON THIS, CORIN NOW CONSIDER THIS CASE CLOSED. 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. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    TAPERFIT REVISION AFTER APPROXIMATELY 1 MONTH DUE TO INFECTION.

    Description of Event or Problem · 0

    CORMET REVISION AFTER APPROXIMATELY 12 YEARS AND 2 MONTHS DUE TO HIP PAIN.

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL REPORT. THE CORMET CUP LOT CODE AND POST PRIMARY AND PRE REVISION X-RAYS HAVE BEEN REQUESTED TO AID THE INVESTIGATION OF THIS EVENT, AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. UPON RECEIPT OF THE APPROPRIATE DEVICE DETAILS, THE RELEVANT DEVICE MANUFACTURING RECORDS SHALL BE IDENTIFIED AND REVIEWED. THE EXPLANTED DEVICES HAVE BEEN RETURNED AND WILL BE REVIEWED AT CORIN. 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

    CORMET REVISION AFTER APPROXIMATELY 12 YEARS AND 2 MONTHS DUE TO HIP PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808699 CORMET HIP RESURFACING PROSTHESIS NXT CORIN GROUP 179.256B 058227

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R BIOLOX CERAMIC HEAD - 104.4005, 393463.| CEMENT RESTRICTOR - 588.0002, 396552.| CORMET HEAD - E079.748, JNYS.| CORMET HEAD - E079.748, JNYS.| TRINITY ECIMA LINER - 322.04.640, 274241.| BIOLOX CERAMIC HEAD - 104.4005, 393463| CEMENT RESTRICTOR - 588.0002, 396552| CORMET HEAD - E079.748, JNYS| TRINITY ECIMA LINER - 322.04.640, 274241