MAUDE Adverse Event Report: ZIMMER VERSYS HIP REPLACEMENT SYSTEM

Catalog Number 01-00551-204EDI

Device Problem Nonstandard Device (1420)

Patient Problem Pain (1994)

Event Date 10/15/2015

Event Type  Injury  

Event Description

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.

• Brand Name: VERSYS HIP REPLACEMENT SYSTEM
• Type of Device: VERSYS HIP REPLACEMENT SYSTEM
• Manufacturer (Section D): ZIMMER
• MDR Report Key: 6135168
• MDR Text Key: 61258729
• Report Number: MW5066385
• Device Sequence Number: 1
• Product Code: LWJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/28/2016
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 01-00551-204EDI
• Device Lot Number: 2772959
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/28/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTC MEDS: ENSURES; OXYCONTIN; RX MEDS: GABAPENTIN; VALIUM
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 66 YR
• Patient Weight: 67