MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DURACON PLASTIC PATELLA MED; KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P

Device Problem Unstable (1667)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

The initial mdr was incorrectly submitted as follow up #1.This record is for the correction to initial report.

Event Description

Patient implanted sometime in 1999.Right knee is unstable over time and painful.Note there are no lot #'s on some of the implants due to not having information and they were covered with bone upon removal.

• Brand Name: DURACON PLASTIC PATELLA MED
• Type of Device: KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5123796
• MDR Text Key: 199461822
• Report Number: 0002249697-2015-03215
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1