BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TRIATHLON TS SIZE 5

    MDR report key: 2070924 · Received April 19, 2011

    Report

    Report Number
    2249697-2011-00517
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    May 19, 2009
    Report Date
    March 28, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER DEVICES WERE ALSO LISTED IN THIS REPORT: UNKNOWN TRIATHLON PS INSERT, CAT# UNK, LOT# UNK. UNKNOWN SIMPLEX P WITH TOBRAMYCIN, CAT# UNK, # UNK. AT THE PRESENT TIME IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S ALLERGIC REACTION. 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 PERTAINING TO THE DEVICE(S) REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT'S HUSBAND E-MAIL STRYKER AND STATED "ANITA HAD A KNEE REVISION (B)(6) 2009 AT PORTER HOSPITAL. THERE APPEARS TO BE A "LOOSENING" OF THE REPLACEMENT. HER SURGEON HAS SENT HER TO AN ALLERGIST WHO IS ASKING US ABOUT "MATERIALS" IN THE KNEE REVISION. HE FURTHER STATED IN A FOLLOW UP E-MAIL THAT "THIS 2ND KNEE REVISION IS NOT GOING WELL AFTER 16 MONTHS. BONE SCANS AND PAIN ARE LEADING THE DR. (B)(6) TO ENTERTAIN A "LOOSENING" OF THE KNEE IMPLANT (TRIATHLON TS) AS THE CAUSE. BECAUSE OF HER HISTORY, HE THINKS THAT PERHAPS AN ALLERGIC REACTION TO SOME OF THE METAL OR NON-METAL CONSTITUENTS OF THE KNEE REPLACEMENT MAY BE THE ROOT CAUSE OF MY WIFE'S UNSUCCESSFUL 3 KNEE IMPLANT/REVISIONS UPON HER LEFT KNEE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN TRIATHLON TS SIZE 5 IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other