BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, ø 40/+3.5, TAPER 12/14 N/A 00877504003

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-30 for BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, ø 40/+3.5, TAPER 12/14 N/A 00877504003 manufactured by Biomet Uk Ltd..

MAUDE Entry Details

• Report Number: 3002806535-2020-00194
• MDR Report Key: 9897630
• Report Source: OTHER
• Date Received: 2020-03-30
• Date of Report: 2020-03-30
• Date of Event: 2012-05-11
• Date Mfgr Received: 2020-03-04
• Date Added to Maude: 2020-03-30
• 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: MS. CHRISTINA ARNT
• Manufacturer Street: 56 E. BELL DR.
• Manufacturer City: WARSAW IN 46582
• Manufacturer Country: US
• Manufacturer Postal: 46582
• Manufacturer Phone: 5745273773
• Manufacturer G1: BIOMET UK LTD.
• Manufacturer Street: WATERTON INDUSTRIAL ESTATES
• Manufacturer City: BRIDGEND CF313XA
• Manufacturer Country: UK
• Manufacturer Postal Code: CF31 3XA
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: N/A
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, ø 40/+3.5, TAPER 12/14
• Generic Name: HIP ARTHROPLASTY
• Product Code: LZO
• Date Received: 2020-03-30
• Model Number: N/A
• Catalog Number: 00877504003
• Lot Number: 2606708
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BIOMET UK LTD.
• Manufacturer Address: WATERTON INDUSTRIAL ESTATES BRIDGEND CF313XA UK CF31 3XA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2020-03-30