MAUDE Adverse Event Report: DEPUY LOW PROFILE POLY PATELLA

Catalog Number 1294-09-450

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Pain (1994)

Event Date 09/25/2013

Event Type  Injury  

Event Description

Total right knee replacement on (b)(6) 2013 at (b)(6).Terrible pain unable to do many chores and other activities previously done.Extreme pain of the knee since then.Dr prescribe many opiates.Have hfa (high frequency neurotomy/ablation) at (b)(6).Now must continue with another set of injections for steroids.Have severe inflammation of the nerve endings.

• Brand Name: LOW PROFILE POLY PATELLA
• Type of Device: LOW PROFILE POLY PATELLA
• Manufacturer (Section D): DEPUY
• MDR Report Key: 4895115
• MDR Text Key: 19033397
• Report Number: MW5043575
• Device Sequence Number: 4
• Product Code: HRY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 1294-09-450
• Device Lot Number: 3613482
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/01/2015
• Patient Sequence Number: 1
• Treatment: LORAZEPAM; EPLERENONE; GUERTOCIVE; UIT B COMPLEX; CARVEDILOL; CALCIUM + LAD; CRESTOR; SYNTHROID; ASPIRIN (81MG); IRBESARTAY; DIAZEPAM; CLONIDINE
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 80 YR