BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM

    MDR report key: 2993373 · Received March 7, 2013

    Report

    Report Number
    0002249697-2013-00930
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    November 18, 2011
    Report Date
    February 6, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K072221
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S WEIGHT WAS CORRECTED BASED ON ADDITIONAL INFORMATION. THE PATIENT IS (B)(6). AN EVENT REGARDING PAIN AND INSTABILITY INVOLVING A TRIATHLON INSERT WAS REPORTED. THE REPORTED INSTABILITY COULD NOT BE CONFIRMED, HOWEVER, THE PAIN WAS CONFIRMED. REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED THE REPORTED PAIN IS CAUSED BY PERIPHERAL NEUROPATHY. THE REPORTED INSTABILITY COULD NOT BE CONFIRMED. DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE INVESTIGATION CONCLUDED THAT THE REPORTED PAIN IS CAUSED BY PERIPHERAL NEUROPATHY, OR PAIN DUE TO NERVE DAMAGE. HOWEVER, THE REPORTED INSTABILITY COULD NOT BE CONFIRMED. THERE IS NO INDICATION IN THE PROVIDED INFORMATION OR MEDICAL RECORDS THAT THIS EVENT IS DEVICE RELATED. THE FOLLOWING PRODUCTS ARE INCLUDED IN THIS REPORT AND ARE INCLUDED IN THE INVESTIGATION: CATALOG #: 5521-B-600; TRI TS BASEPLATE SIZE 6; LOT: FPWO CATALOG #: 5515-F-601; TRIATHLON PS FEM COMPONENT, CEMENTED; LOT: EBSP CATALOG #: 5537-G-613; NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM; LOT: MKHWTH

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN LEFT STRYKER KNEE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: PATIENT STATES PAIN. KNEE BENDS BACKWARDS TO FAR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: PATIENT STATES PAIN. KNEE BENDS BACKWARDS TO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97448 NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MKHWTH

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other