BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON ASYM PATELLA A38X11

    MDR report key: 2974556 · Received February 22, 2013

    Report

    Report Number
    0002249697-2013-00756
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 29, 2013
    Report Date
    February 1, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K040267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).AT THIS TIME, IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. (B)(4): NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN FROM A PULMONARY EMBOLISM INVOLVING A TRIATHLON ASYMMETRIC PATELLA WAS REPORTED. WHILE THE EVENT REGARDING A PULMONARY EMBOLISM AFTER A TRIATHLON KNEE ARTHROPLASTY WAS CONFIRMED, IT WAS DETERMINED NOT TO BE DEVICE RELATED. REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED ¿TE COMPLICATIONS AFTER TKA ARE CAUSED BY A MIX OF FACTORS PARTLY RELATING TO PATIENT GENETIC PREDISPOSITION AND FACTORS PRESENT IN THE SURGICAL PROCEDURE OF TOTAL KNEE ARTHROPLASTY. THERE IS NO INFORMATION AVAILABLE IN THE SCIENTIFIC LITERATURE THAT WOULD RELATE THROMBO-EMBOLIC EVENTS TO SPECIFIC DESIGN FACTORS OF IMPLANTS IN GENERAL OR THE SPECIFIC IMPLANT IN QUESTION. THE ROOT CAUSE OF PULMONARY EMBOLUS IN THIS CASE IS MOSTLY PROCEDURE-RELATED WITH AN UNKNOWN FURTHER CONTRIBUTION BY PATIENT-RELATED FACTORS SUCH AS OBESITY IN THIS CASE AND AS SUCH IS NOT DEVICE-RELATED. BASED ON THE PROVIDED INFORMATION, THE PRODUCT REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT CAME IN WITH PAIN IN HIS KNEE. (LEFT SIDE). A PULMONARY EMBOLISM OCCURS WITH PATIENT 01008 AFTER SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT CAME IN WITH PAIN IN HIS KNEE. (LEFT SIDE). A PULMONARY EMBOLISM OCCURS WITH PATIENT (B)(6) AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77700 TRIATHLON ASYM PATELLA A38X11 IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH LCR926

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other