MAUDE Adverse Event Report: STRYKER STRYKER TRIATHLON; STRYKER TRIATHLON

Model Number EDJHH (5520-B-500)

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Date 07/14/2021

Event Type  Injury  

Event Description

In 2013 pt had left total knee replacement - w/ stryker triathlon implant.In 2021 pt developed left knee pain and swelling; x-rays showed "failure of the femoral component; bone scan showed "signs of aseptic loosening." pt admitted on (b)(6) 2021 for planned revision left total knee.

• Brand Name: STRYKER TRIATHLON
• Type of Device: STRYKER TRIATHLON
• Manufacturer (Section D): STRYKER ; 1141 n. robinson ave.; okc OK 73103
• MDR Report Key: 12307228
• MDR Text Key: 266378195
• Report Number: 12307228
• Device Sequence Number: 1
• Product Code: MBH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EDJHH (5520-B-500)
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/14/2021
• Device Age: 8 YR
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 95