CPLT KNEE KIT 5CC 11G SIDE N/A 414.502

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-09-11 for CPLT KNEE KIT 5CC 11G SIDE N/A 414.502 manufactured by Zimmer Knee Creations, Inc..

MAUDE Entry Details

• Report Number: 3008812173-2019-00043
• MDR Report Key: 8995462
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2019-09-11
• Date of Report: 2019-11-14
• Date of Event: 2019-05-20
• Date Facility Aware: 2019-05-20
• Date Mfgr Received: 2019-08-13
• Device Manufacturer Date: 2018-08-09
• Date Added to Maude: 2019-09-11
• 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. LEO MUNAR
• Manufacturer Street: 841 SPRINGDALE DRIVE
• Manufacturer City: EXTON PA 19341
• Manufacturer Country: US
• Manufacturer Postal: 19341
• Manufacturer Phone: 4848794553
• Manufacturer G1: ZIMMER KNEE CREATIONS, INC.
• Manufacturer Street: 841 SPRINGDALE DRIVE
• Manufacturer City: EXTON PA 19341
• Manufacturer Country: US
• Manufacturer Postal Code: 19341
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: N/A
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CPLT KNEE KIT 5CC 11G SIDE
• Generic Name: SCP KIT
• Product Code: OJH
• Date Received: 2019-09-11
• Model Number: N/A
• Catalog Number: 414.502
• Lot Number: KC05347
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: 1 MO
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ZIMMER KNEE CREATIONS, INC.
• Manufacturer Address: 841 SPRINGDALE DRIVE EXTON PA 19341 US 19341

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-09-11