ANTEVERSION OSTEOTOME MED 200225000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-08-12 for ANTEVERSION OSTEOTOME MED 200225000 manufactured by Depuy Orthopaedics, Inc. 1818910.

MAUDE Entry Details

• Report Number: 1818910-2019-100828
• MDR Report Key: 8885235
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2019-08-12
• Date of Report: 2019-07-22
• Date of Event: 2019-01-22
• Date Mfgr Received: 2019-10-07
• Device Manufacturer Date: 2015-10-22
• Date Added to Maude: 2019-08-12
• 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: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. KARA DITTY-BOVARD
• Manufacturer Street: 1210 WARD AVENUE
• Manufacturer City: WEST CHESTER IN 193800988
• Manufacturer Country: US
• Manufacturer Postal: 193800988
• Manufacturer Phone: 6103142063
• Manufacturer G1: DEPUY ORTHOPAEDICS, INC. 1818910
• Manufacturer Street: 700 ORTHOPAEDIC DRIVE
• Manufacturer City: WARSAW IN 465820988
• Manufacturer Country: US
• Manufacturer Postal Code: 465820988
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ANTEVERSION OSTEOTOME MED
• Generic Name: HIP INSTRUMENTS : CUTTING INSTRUMENTS
• Product Code: HWM
• Date Received: 2019-08-12
• Returned To Mfg: 2019-08-09
• Catalog Number: 200225000
• Lot Number: SO2018680
• 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. 1818910
• Manufacturer Address: 700 ORTHOPAEDIC DRIVE WARSAW IN 465820988 US 465820988

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-08-12