TPRLC 133 T1 PPS HO 15X150MM 0MM T1 N/A 51-104150

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 2019-12-19 for TPRLC 133 T1 PPS HO 15X150MM 0MM T1 N/A 51-104150 manufactured by Zimmer Biomet, Inc..

MAUDE Entry Details

• Report Number: 0001825034-2019-05653
• MDR Report Key: 9498031
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2019-12-19
• Date of Report: 2020-03-11
• Date of Event: 2019-11-26
• Date Mfgr Received: 2020-03-06
• Device Manufacturer Date: 2017-06-02
• Date Added to Maude: 2019-12-19
• 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: 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: N/A
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: TPRLC 133 T1 PPS HO 15X150MM 0MM T1
• Generic Name: PROSTHESIS, HIP
• Product Code: MAY
• Date Received: 2019-12-19
• Returned To Mfg: 2020-01-20
• Model Number: N/A
• Catalog Number: 51-104150
• Lot Number: 6057600
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• 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		2019-12-19