MAUDE Adverse Event Report: ZIMMER INC. VERSYS PROVISIONAL FEMORAL HEAD

Catalog Number 00789503604

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/11/2014

Event Type  Injury  

Event Description

It is reported that when the surgeon was putting the patient's hip through a trial reduction it dislocated anteriorly.The trial head came off the neck trial, and was believed to have moved into the patient's pelvis.A c-arm and ultrasound were used to attempt to locate the trial head, but was unable to be found.The trial head was left inside the patient initially, on (b)(6) 2014.The patient underwent a laparoscopic surgery to remove the instrument, on (b)(6) 2014.

Manufacturer Narrative

This report will be amended when our investigation is complete.

• Brand Name: VERSYS PROVISIONAL FEMORAL HEAD
• Manufacturer (Section D): ZIMMER INC.; p.o. box 708; warsaw IN 46581 070
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4410081
• MDR Text Key: 15324929
• Report Number: 1822565-2015-00026
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00789503604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 101