BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X3 TRIATHLON CS INS SIZE4 11MM

    MDR report key: 4090578 · Received September 15, 2014

    Report

    Report Number
    0002249697-2014-03469
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    May 14, 2014
    Report Date
    August 20, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K063423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VI, AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING LIMITED ROM INVOLVING A X3 TRIATHLON CS INSERT WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS NO ITEMS WERE RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: INSUFFICIENT MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. DEVICE HISTORY REVIEW: CONFIRMED ALL DEVICES ACCEPTED INTO FINISHED GOODS CONFORMED TO SPECIFICATION COMPLAINT HISTORY REVIEW: INDICATED THERE WAS 1 OTHER EVENT REPORTED FOR THE MANUFACTURING LOT. THE EVENT WAS NOT RELATED TO THIS INVESTIGATION. A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED ..."THE PI AS SUBMITTED DOES NOT HAVE ENOUGH INFORMATION TO EVALUATE WHETHER THE DEVICE CONTRIBUTED TO THE COMPLAINT AS SUBMITTED (PRE OP PLANNING AND SEGMENTATION AS WELL AS POSTOP X-RAYS AND REASON FOR THE INQUIRY ARE REQUIRED FOR ADEQUATE EVALUATION)." NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    PATIENT IS PARTICIPANT IN (B)(6) STUDY. PATIENT HAD LEFT KNEE INSTABILITY AND HAD EUA (EXAMINATION UNDER ANAESTHESIA) / MANIPULATION. LEFT KNEE ON 14 MAY 2014.

    Description of Event or Problem · 1

    PATIENT IS PARTICIPANT IN SHAPEMATCH STUDY. PATIENT HAD LEFT KNEE INSTABILITY AND HAD EUA (EXAMINATION UNDER ANAESTHESIA) / MANIPULATION. LEFT KNEE ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570267 X3 TRIATHLON CS INS SIZE4 11MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH LCD866

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention