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

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).

• Brand Name: STRYKER ROBOTIC KNEE REPLACEMENT DEVICE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER CORP.
• MDR Report Key: 10194756
• MDR Text Key: 196770118
• Report Number: MW5095206
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 06/24/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 66 YR
• Patient Weight: 63