MAUDE Adverse Event Report: DEPUY ROTATING PLATFORM KNEE

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 02/05/2014

Event Type  Injury  

Event Description

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.

• Brand Name: ROTATING PLATFORM KNEE
• Type of Device: ROTATING PLATFORM KNEE
• Manufacturer (Section D): DEPUY
• MDR Report Key: 3636767
• MDR Text Key: 3985251
• Report Number: MW5034556
• Device Sequence Number: 1
• Product Code: HRZ
• 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: 02/11/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 54 YR
• Patient Weight: 95