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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER CORP. STRYKER ROBOTIC KNEE REPLACEMENT DEVICE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

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STRYKER CORP. STRYKER ROBOTIC KNEE REPLACEMENT DEVICE; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Device Problem Product Quality Problem (1506)
Patient Problems Pain (1994); Swelling (2091); Therapeutic Effects, Unexpected (2099)
Event Date 04/16/2019
Event Type  Injury  
Event Description
I have had degenerative joint problems in both knees.My right knee was often painful and occasionally swollen and when injections did not help much my local (b)(6) sports medicine doctor recommended knee replacements.I did not need a walker or cane at the time except about four times a year if it swelled for a few days.I researched online and found (b)(6) sports medicine and orthopedic in (b)(6) at (b)(6) which claimed that using stryker robotic for knee replacement was more accurate and had less complications than traditional knee replacement method.They assured me they would not only repair my right knee but straighten it as i was slightly knock knees.Their dr (b)(6) did the surgery.I completed physical therapy through insurance and did six more months on my own.My knee is worse than before the operation.It is very bent to the inside and collapses randomly.I am not stable at all without a cane or a walker.The doctor basically said sorry we need to do another knee replacement without the robot, and use a larger device.They offer no explanations and compensation and basically stryker has not answered my last attempt at communication.I am extremely displeased.(b)(6) and (b)(6) sports medicine have all of my records and xrays and you have permission to access them.Thank you.(b)(6).
 
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Brand Name
STRYKER ROBOTIC KNEE REPLACEMENT DEVICE
Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER CORP.
MDR Report Key10194756
MDR Text Key196770118
Report NumberMW5095206
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/24/2020
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age66 YR
Patient Weight63
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