HIP BA BIO 28MM 12/14 + 8.5 9111123

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 2020-03-05 for HIP BA BIO 28MM 12/14 + 8.5 9111123 manufactured by Depuy International Ltd - 8010379.

MAUDE Entry Details

• Report Number: 1818910-2020-06939
• MDR Report Key: 9793266
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2020-03-05
• Date of Report: 2019-08-08
• Date of Event: 2019-01-01
• Date Mfgr Received: 2020-03-27
• Device Manufacturer Date: 2005-10-13
• Date Added to Maude: 2020-03-05
• 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: KARA DITTY-BOVARD
• Manufacturer Street: 700 ORTHOPAEDIC DR.
• Manufacturer City: WARSAW IN 465810988
• Manufacturer Country: US
• Manufacturer Postal: 465810988
• Manufacturer Phone: 6107428552
• Manufacturer G1: DEPUY IRELAND - 9616671
• Manufacturer Street: LOUGHBEG RINGASKIDDY CO.
• Manufacturer City: CORK
• Manufacturer Country: EI
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HIP BA BIO 28MM 12/14 + 8.5
• Generic Name: ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
• Product Code: KXA
• Date Received: 2020-03-05
• Catalog Number: 9111123
• Lot Number: 1980845
• Device Expiration Date: 2010-10-31
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DEPUY INTERNATIONAL LTD - 8010379
• Manufacturer Address: ST. ANTHONY'S ROAD LEEDS LS118DT UK LS11 8DT

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-03-05