MAUDE Adverse Event Report: STRYKER ANNGROVE TRIATHLON; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Patient Problems Failure of Implant (1924); Inflammation (1932); Pain (1994); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Date 11/11/2020

Event Type  Injury  

Event Description

Diagnosed with severe arthritis in left knee and had a total knee replacement on (b)(6), 2020.The surgeon used the stryker triathlon and mako navigation system.I never fully recovered, and had severe instability with extensive pain and swelling that worsened approximately 4 months post surgery.Despite extensive physical therapy, i needed to have revision surgery on (b)(6) 2022.The surgeon confirmed global instability of the knee, with mechanical loosening of the prosthetic.A 13 mm polyethylene insert was installed to replace the original 9 mm insert.Two years since the revision surgery i continue to have swelling and pain, with some residual instability that is causing other soft tissue inflammation in my leg.I have been forced to use an external knee brace to address the instability and have had a spinal stimulator implanted to assist with the pain.I recently received another specialist diagnosis on (b)(6) 2024 indicating that i have flexion and extension mismatch that is due to over resection of the posterior femur in the first surgery.It is my understanding that the stryker implant when used with the mako navigation system does not allow over resection of bone to occur, and wanted to make you aware of the possible defect in the system.Reference report: mw5154366.

• Brand Name: TRIATHLON
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ANNGROVE
• MDR Report Key: 19203759
• MDR Text Key: 341422710
• Report Number: MW5154365
• Device Sequence Number: 1
• Product Code: JWH
• 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
• Report Date: 04/23/2024

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White