BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAGLIDE+

    MDR report key: 6666168 · Received June 26, 2017

    Report

    Report Number
    9614209-2017-00042
    Event Type
    Malfunction
    Date Received
    June 26, 2017
    Date of Event
    May 19, 2017
    Report Date
    November 24, 2017
    Manufacturer
    CORIN MEDICAL
    Product Code
    JWH
    PMA / PMN Number
    K000232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL REPORT. ADDITIONAL INFORMATION, INCLUDING X-RAYS, OPERATIVE NOTES, AN UPDATED PATIENT OUTCOME AND RETURN OF THE FEMORAL TRIAL HAS BEEN REQUESTED TO AID THIS INVESTIGATION, AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE APPROPRIATE DEVICE DETAILS HAVE BEEN PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WILL BE IDENTIFIED AND REVIEWED. 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. DEVICE WAS IMPLANTED.

    Additional Manufacturer Narrative · 1

    PER -368 FINAL REPORT. ADDITIONAL INFORMATION, INCLUDING X-RAYS, OPERATIVE NOTES, AN UPDATED PATIENT OUTCOME, THE RTK+ FEMORAL TRIAL, PATIENT BONE QUALITY AND DETAILS REGARDING THE IDENTIFICATION OF THE DISCREPANCY WAS REQUESTED IN ORDER TO PROGRESS WITH THIS INVESTIGATION, HOWEVER, NOT ALL HAVE BEEN PROVIDED TO CORIN AND THUS THERE WAS ONLY LIMITED INFORMATION AVAILABLE FOR THE INVESTIGATION. THE RTK+ FEMORAL TRIAL WAS RETURNED AND WAS INSPECTED AT CORIN WITH A RTK+ FEMORAL COMPONENT FROM THE SAME BATCH AS REPORTED IN THIS EVENT. IT WAS FOUND THAT BOTH DEVICES CONFORMED TO SPECIFICATION. A COMPLAINTS TREND HAS BEEN CONDUCTED AND CORIN HAS NOT RECEIVED ANY OTHER REPORTS OF THIS ISSUE OR ANY REPORTS RELATED TO THESE BATCHES. BASED ON THE INFORMATION PROVIDED, NO FURTHER INVESTIGATION CAN BE CONDUCTED AT THIS TIME AND CORIN NOW CONSIDER THIS CASE CLOSED. HOWEVER, SHOULD ANY ADDITIONAL INFORMATION BE PROVIDED THEN THIS CASE MAY BE RE-OPENED FOR FURTHER INVESTIGATION. 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

    THE ROTAGLIDE+ IMPLANT DID NOT FIT WITH THE PREPARED FEMUR. THE DRILL HOLES WERE IN A DIFFERENT POSITION TO THE PEGS ON THE IMPLANT.

    Description of Event or Problem · 1

    THE ROTAGLIDE+ IMPLANT DID NOT FIT WITH THE PREPARED FEMUR. THE DRILL HOLES WERE IN A DIFFERENT POSITION TO THE PEGS OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446900 ROTAGLIDE+ MODULAR KNEE SYSTEM WITH FIXED MENISCUS JWH CORIN MEDICAL 117.413P 335248

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization