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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER STRYKER TRIATHLON TOTAL KNEE REPLACEMENT

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STRYKER STRYKER TRIATHLON TOTAL KNEE REPLACEMENT Back to Search Results
Device Problems Mechanical Problem (1384); Therapeutic or Diagnostic Output Failure (3023); Noise, Audible (3273)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Disability (2371); Numbness (2415); Ambulation Difficulties (2544)
Event Date 08/19/2014
Event Type  Injury  
Event Description

Had a stryker triathlon total knee replacement on (b)(6) 2014. In (b)(6), my knee started popping out of place or 'hydroplaning' as the doctor would describe and causing chronic pain. I informed my doctor and pt of this and was told it was normal until my muscles stabilize. It is now (b)(6) 2015 and the popping has gotten worse, with loud clicks and grinds with any movement of my leg. I cannot bend my knee back without pain. I cannot stand or walk without a cane and sometimes or something presses up against it and it causes great pain. I have not been able to sustain any employment, due to the fact that i cannot stand long without my knee going numb, and i can only walk short distance because my knee is constantly in pain. I cannot drive relief as well as being in fear of having an accident. My doctor has been informed of these symptoms and he has failed to do any tests to see what is going on.

 
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Brand NameSTRYKER TRIATHLON TOTAL KNEE REPLACEMENT
Type of DeviceSTRYKER TRIATHLON TOTAL KNEE REPLACEMENT
Manufacturer (Section D)
STRYKER
MDR Report Key5310976
MDR Text Key33964318
Report NumberMW5058576
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 12/15/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/15/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 12/15/2015 Patient Sequence Number: 1
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