OXFORD UNI TWIN-PEG FEMORAL SM N/A 166941

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 2020-02-03 for OXFORD UNI TWIN-PEG FEMORAL SM N/A 166941 manufactured by Biomet Uk Ltd..

MAUDE Entry Details

• Report Number: 3002806535-2020-00061
• MDR Report Key: 9658739
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2020-02-03
• Date of Report: 2020-02-01
• Date of Event: 2019-11-21
• Date Mfgr Received: 2019-11-22
• Device Manufacturer Date: 2019-06-04
• Date Added to Maude: 2020-02-03
• 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: OXFORD UNI TWIN-PEG FEMORAL SM
• Generic Name: KNEE PROSTHESIS
• Product Code: NRA
• Date Received: 2020-02-03
• Returned To Mfg: 2020-01-11
• Model Number: N/A
• Catalog Number: 166941
• Lot Number: J6565293
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: *
• 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. Other	2020-02-03