BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON ASYMMETRIC X3 PATELLA

    MDR report key: 2001645 · Received February 22, 2011

    Report

    Report Number
    2249697-2011-00204
    Event Type
    Injury
    Date Received
    February 22, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 3, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE(S) CANNOT BE PERFORMED AS THE DEVICE(S) REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THE FOLLOWING OTHER DEVICES WERE LISTED IN THIS REPORT: TRIATHLON CR X3 TIBIAL INSERT: CAT# 5530-G-7116, LOT LBC562. TRIATHLON-PRIM TIB BASEPLATE CEMENTED #7: CAT# 5520-B-700, LOT UNKNOWN. TRIATHLON-CR FEMORAL COMPONENT CEMENTED #7 RIGHT: CAT# 5510-F-702, LOT JB121. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CONTACTED HIS SURGEON DR. (B)(6) AND WANTED TO KNOW IF HIS BILATERAL KNEE REPLACEMENTS WERE PART OF RECALL. SALES REP (B)(6) CONTACTED THE HOTLINE ON (B)(6), 2011 TO FIND OUT IF IMPLANTS WERE PART OF A RECALL. THE IMPLANTS LISTED ARE FROM THE PATIENT RIGHT TOTAL KNEE REPLACEMENT. ADDITIONAL INFORMATION: PATIENT STATED THAT HE HAS BEEN EXPERIENCING PAIN IN HIS RIGHT KNEE AND IS SCHEDULED FOR A REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON ASYMMETRIC X3 PATELLA IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA 801E

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other