EXPLOR 8X28MM IMPL STEM W/SCR NI 11-210063

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2020-03-10 for EXPLOR 8X28MM IMPL STEM W/SCR NI 11-210063 manufactured by Zimmer Biomet, Inc..

MAUDE Entry Details

• Report Number: 0001825034-2020-01063
• MDR Report Key: 9810964
• Report Source: CONSUMER,HEALTH PROFESSIONAL
• Date Received: 2020-03-10
• Date of Report: 2020-03-10
• Date of Event: 2019-02-11
• Date Mfgr Received: 2020-02-18
• Device Manufacturer Date: 2014-03-06
• Date Added to Maude: 2020-03-10
• 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: ZIMMER BIOMET, INC.
• Manufacturer Street: 56 E. BELL DRIVE
• Manufacturer City: WARSAW IN 46582
• Manufacturer Country: US
• Manufacturer Postal Code: 46582
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: NI
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: EXPLOR 8X28MM IMPL STEM W/SCR
• Generic Name: PROSTHESIS, EXTREMITIES
• Product Code: KWI
• Date Received: 2020-03-10
• Model Number: NI
• Catalog Number: 11-210063
• Lot Number: 393080
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ZIMMER BIOMET, INC.
• Manufacturer Address: 56 E. BELL DRIVE WARSAW IN 46582 US 46582

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2020-03-10