UNKNOWN SIZE 6 RIGHT TS FEMORAL COMPONENT UNK_JR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2019-11-13 for UNKNOWN SIZE 6 RIGHT TS FEMORAL COMPONENT UNK_JR manufactured by Stryker Orthopaedics-mahwah.

MAUDE Entry Details

• Report Number: 0002249697-2019-03756
• MDR Report Key: 9315649
• Report Source: HEALTH PROFESSIONAL,OTHER
• Date Received: 2019-11-13
• Date of Report: 2019-11-13
• Date of Event: 2019-10-16
• Date Mfgr Received: 2019-10-16
• Date Added to Maude: 2019-11-13
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. COLLIN NEITZEL
• Manufacturer Street: 325 CORPORATE DRIVE
• Manufacturer City: MAHWAH NJ 07430
• Manufacturer Country: US
• Manufacturer Postal: 07430
• Manufacturer Phone: 2018315000
• Manufacturer G1: STRYKER ORTHOPAEDICS-MAHWAH
• Manufacturer Street: 325 CORPORATE DRIVE
• Manufacturer City: MAHWAH NJ 07430
• Manufacturer Country: US
• Manufacturer Postal Code: 07430
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: UNKNOWN SIZE 6 RIGHT TS FEMORAL COMPONENT
• Generic Name: KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P
• Product Code: NPJ
• Date Received: 2019-11-13
• Catalog Number: UNK_JR
• Lot Number: UNKNOWN
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: STRYKER ORTHOPAEDICS-MAHWAH
• Manufacturer Address: 325 CORPORATE DRIVE MAHWAH NJ 07430 US 07430

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2019-11-13