DEPUY FEMORAL COMPONENT 129402060

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-04-30 for DEPUY FEMORAL COMPONENT 129402060 manufactured by Depuy.

Event Text Entries

[3403157] Had a depuy knee replacement and knee gives out causing me to fall, severe constant pain, and fluid build up.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5030037
• MDR Report Key: 3096001
• Date Received: 2013-04-30
• Date of Report: 2013-04-30
• Date of Event: 2009-04-12
• Date Added to Maude: 2013-05-08
• 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
• Reporter Occupation: PATIENT
• 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: DEPUY FEMORAL COMPONENT
• Generic Name: KNEE REPLACEMENT
• Product Code: HSA
• Date Received: 2013-04-30
• Catalog Number: 129402060
• Lot Number: 2787901
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DEPUY

Device Sequence Number: 2

• Brand Name: TIBIAL BASE PLATE
• Generic Name: KNEE REPLACEMENT
• Product Code: HSA
• Date Received: 2013-04-30
• Lot Number: 129433140
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: DEPUY

Patients

Patient Number	Treatment	Outcome	Date
1	7	1. Other	2013-04-30