TRIATHLON TOTAL KNEE REPLACEMENT 5515P501

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-29 for TRIATHLON TOTAL KNEE REPLACEMENT 5515P501 manufactured by Stryker.

Event Text Entries

[4409049] Infected total knee with removal of implants and revision.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5036418
• MDR Report Key: 3845951
• Date Received: 2014-05-29
• Date of Report: 2014-05-28
• Date of Event: 2014-04-30
• Date Added to Maude: 2014-06-04
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: TRIATHLON TOTAL KNEE REPLACEMENT
• Generic Name: KNEE REPLACEMENT COMPONENT
• Product Code: JWH
• Date Received: 2014-05-29
• Model Number: 5515P501
• Catalog Number: 5515P501
• Lot Number: ISUPA
• Operator: HEALTH PROFESSIONAL
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: STRYKER

Device Sequence Number: 2

• Brand Name: TIBIAL BEARING INSERT
• Generic Name: BEARING INSERT
• Product Code: HSH
• Date Received: 2014-05-29
• Model Number: 5532G513
• Catalog Number: 5532G513
• Lot Number: MLRHNW
• Operator: HEALTH PROFESSIONAL
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: STRYKER

Device Sequence Number: 3

• Brand Name: TIBIAL BEARING BASE
• Generic Name: BEARING BASE
• Product Code: HSH
• Date Received: 2014-05-29
• Model Number: 5520B500
• Catalog Number: 5520B500
• Lot Number: EE961
• Operator: HEALTH PROFESSIONAL
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: STRYKER

Device Sequence Number: 4

• Brand Name: ASYMETRICAL PATELLA
• Generic Name: PATELLA
• Product Code: JWH
• Date Received: 2014-05-29
• Model Number: 5551G320
• Catalog Number: 5551G320
• Lot Number: 3A2H
• Operator: HEALTH PROFESSIONAL
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: STRYKER

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2014-05-29