NATURAL KNEE II SYSTEM-RIGHT KNEE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-01 for NATURAL KNEE II SYSTEM-RIGHT KNEE manufactured by Zimmer.

Event Text Entries

[5054243] Pt called to report adverse reactions caused by her natural knee ii system-right knee. Pt stated that in (b)(6) 2012, her right knee gave out and she fell. She also said her shin was very sore. She said she was seen by a physician who told her that her right knee implant was either loose, or she had an infection. It was confirmed by a physician that the cement in the right knee implant had come loose. She stated that up until (b)(6) 2012, the right knee implant never really felt right, she said it felt tight. She said she has spoken with 10 attorneys, and was told this implant was not one that was recalled. Pt is very upset.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5039314
• MDR Report Key: 4295022
• Date Received: 2014-12-01
• Date of Report: 2014-12-01
• Date of Event: 2012-09-01
• Date Added to Maude: 2014-12-04
• 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: 3
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: NATURAL KNEE II SYSTEM-RIGHT KNEE
• Generic Name: MODULAR CEMENTED TIBIAL BASEPLATE
• Product Code: JWH
• Date Received: 2014-12-01
• Lot Number: 61487951
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ZIMMER

Device Sequence Number: 2

• Brand Name: ULTRA CONGRUENT TIBIAL INSERT
• Generic Name: INSERT
• Product Code: HSH
• Date Received: 2014-12-01
• Lot Number: 81488218
• Device Eval'ed by Mfgr: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: ZIMMER

Device Sequence Number: 3

• Brand Name: PATELLA
• Generic Name: KNEE IMPLANT
• Product Code: JWH
• Date Received: 2014-12-01
• Lot Number: 61516864
• Device Eval'ed by Mfgr: *
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: ZIMMER

Device Sequence Number: 4

• Brand Name: FEMORAL COMPONENT
• Generic Name: FEMORAL
• Product Code: JWH
• Date Received: 2014-12-01
• Lot Number: 61472001
• Device Eval'ed by Mfgr: *
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: ZIMMER

Device Sequence Number: 5

• Brand Name: BONE CEMENT
• Generic Name: CEMENT
• Product Code: LOD
• Date Received: 2014-12-01
• Lot Number: 3115024
• Device Eval'ed by Mfgr: *
• Device Sequence No: 5
• Device Event Key: 0
• Manufacturer: ZIMMER

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2014-12-01