ROTATING PLATFORM KNEE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-02-12 for ROTATING PLATFORM KNEE manufactured by Depuy.

Event Text Entries

[3985251] I have had two total knee replacements with the depuy rotating platform knee. The first one was on my left knee in (b)(6) 2009 and the right knee (b)(6) 2010. The right knee component loosens and causes horrible pain, swelling, unable to walk any distance, unable to do house chores or much of anything else. I had to undergo revision surgery in (b)(6) 2013 on the right knee. The doctor that did the surgery said he didn't understand why it had loosened on the bottom. So after having the surgery my left knee started hurting again swelling tender to touch and i went to the doctor last week and they told me that the left knee is showing signs of loosening also in the same area. These were suppose to last 10 to 15 years. The first surgery was bad but the revision surgery is even worse.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5034556
• MDR Report Key: 3636767
• Date Received: 2014-02-12
• Date of Report: 2014-02-11
• Date of Event: 2014-02-05
• Date Added to Maude: 2014-02-21
• 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: 0
• 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: ROTATING PLATFORM KNEE
• Generic Name: ROTATING PLATFORM KNEE
• Product Code: HRZ
• Date Received: 2014-02-12
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DEPUY

Device Sequence Number: 2

• Brand Name: ROTATING PLATFORM KNEE
• Generic Name: ROTATING PLATFORM KNEE
• Product Code: HRZ
• Date Received: 2014-02-12
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: DEPUY

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Other	2014-02-12