SIG HP RP TIBIA INSERT CASE 950502807

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 2019-10-31 for SIG HP RP TIBIA INSERT CASE 950502807 manufactured by Depuy Orthopaedics Inc Us.

MAUDE Entry Details

• Report Number: 1818910-2019-113345
• MDR Report Key: 9260718
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2019-10-31
• Date of Report: 2019-10-07
• Date of Event: 2019-10-07
• Date Mfgr Received: 2019-11-15
• Device Manufacturer Date: 2008-08-15
• Date Added to Maude: 2019-10-31
• 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: MRS. KARA DITTY-BOVARD
• Manufacturer Street: 1210 WARD AVENUE
• Manufacturer City: WEST CHESTER PA 19380
• Manufacturer Country: US
• Manufacturer Postal: 19380
• Manufacturer Phone: 6107428552
• Manufacturer G1: DEPUY ORTHOPAEDICS, INC. 1818910
• Manufacturer Street: 700 ORTHOPAEDIC DR.
• Manufacturer City: WARSAW IN 465810988
• Manufacturer Country: US
• Manufacturer Postal Code: 465810988
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SIG HP RP TIBIA INSERT CASE
• Generic Name: KNEE INSTRUMENT : INSTRUMENT CASES
• Product Code: FSM
• Date Received: 2019-10-31
• Returned To Mfg: 2019-11-14
• Catalog Number: 950502807
• Lot Number: CL2J34
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DEPUY ORTHOPAEDICS INC US
• Manufacturer Address: 700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-10-31