MAUDE Adverse Event Report: HOWMEDICA OSTEONICS CORP aka Stryker Orthopaedics TRIATHLON KNEE SYSTEM; PROSTHESIS, KNEE

Lot Number S3FAB

Device Problems Structural Problem (2506); Material Protrusion/Extrusion (2979); Noise, Audible (3273)

Patient Problems Pain (1994); Swelling (2091); Weakness (2145); Ambulation Difficulties (2544)

Event Date 12/01/2016

Event Type  Injury  

Event Description

Pt reports she was unable to get up from her bed one morning due to severe pain in her knee.She reports hearing clicks while walking and has experienced weakness, swelling and buckling.Her orthopedic surgeon saw "something sticking out of her bone" and mentioned that "something pulls away" when she moves her knee.Pt is worried her implant may have been recalled.The pt is wearing a knee brace for support and can no longer hear the clicking noise; however, her other symptoms persist.

• Brand Name: TRIATHLON KNEE SYSTEM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): HOWMEDICA OSTEONICS CORP aka Stryker Orthopaedics
• MDR Report Key: 7734746
• MDR Text Key: 115654420
• Report Number: MW5078695
• Device Sequence Number: 0
• Product Code: MBH
• 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: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: S3FAB
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 59