VERSYS HIP REPLACEMENT SYSTEM 01-00551-204EDI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-28 for VERSYS HIP REPLACEMENT SYSTEM 01-00551-204EDI manufactured by Zimmer.

Event Text Entries

[61258729] As the personal representative of my father, i am wanting to know recall numbers for my father who was in great pain after receiving: zimmer (versys hip replacement system); he had the fitmore-hip-stem.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5066385
• MDR Report Key: 6135168
• Date Received: 2016-11-28
• Date of Report: 2016-11-28
• Date of Event: 2015-10-15
• Date Added to Maude: 2016-11-30
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: VERSYS HIP REPLACEMENT SYSTEM
• Generic Name: VERSYS HIP REPLACEMENT SYSTEM
• Product Code: LWJ
• Date Received: 2016-11-28
• Catalog Number: 01-00551-204EDI
• Lot Number: 2772959
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ZIMMER

Device Sequence Number: 2

• Brand Name: BIPOLAR CUPLINER
• Generic Name: LINER
• Product Code: KWB
• Date Received: 2016-11-28
• Model Number: 00500104428
• Catalog Number: 5001-44-28/EDI
• Lot Number: 62831897
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: ZIMMER

Device Sequence Number: 3

• Brand Name: BIPOLAR CUP SHELL
• Generic Name: SHELL
• Product Code: KWA
• Date Received: 2016-11-28
• Model Number: 00500104600
• Catalog Number: 5001-46/EDI
• Lot Number: 62738211
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: ZIMMER

Device Sequence Number: 4

• Brand Name: VERSYS FEMORAL HEAD
• Generic Name: FEMORAL HEAD
• Product Code: LPH
• Date Received: 2016-11-28
• Model Number: 00801802803
• Catalog Number: 8018-28-03
• Lot Number: 62244365
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: ZIMMER

Device Sequence Number: 5

• Brand Name: TAPER 12/14 36MM
• Generic Name: TAPER 12/14 36MM
• Product Code: LPH
• Date Received: 2016-11-28
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 5
• Device Event Key: 0
• Manufacturer: ZIMMER

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit	2016-11-28