COMPLETE ULTAMET MTL 36IDX64OD 121887564

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 2019-08-19 for COMPLETE ULTAMET MTL 36IDX64OD 121887564 manufactured by Depuy Orthopaedics, Inc. 1818910.

MAUDE Entry Details

• Report Number: 1818910-2019-101468
• MDR Report Key: 8907395
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2019-08-19
• Date of Report: 2019-07-29
• Date of Event: 2019-01-01
• Date Mfgr Received: 2019-08-23
• Date Added to Maude: 2019-08-19
• 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 PA 193800988
• Manufacturer Country: US
• Manufacturer Postal: 193800988
• Manufacturer Phone: 6107428552
• Manufacturer G1: DEPUY INTERNATIONAL LTD. 8010379
• Manufacturer Street: ST. ANTHONY'S RD
• Manufacturer City: LEEDS LS118 DT
• Manufacturer Country: UK
• Manufacturer Postal Code: LS11 8 DT
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: COMPLETE ULTAMET MTL 36IDX64OD
• Generic Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
• Product Code: OVO
• Date Received: 2019-08-19
• Catalog Number: 121887564
• Lot Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• 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	1. Required No Informationntervention	2019-08-19