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

Catalog Number 00789503205

Device Problem Disassembly (1168)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/29/2014

Event Type  Injury  

Event Description

It is reported that during trialing of a total hip replacement, the trial head was lost anteriorly and it remains in the patient.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

The medwatch report provided no add'l info concerning the described event of this complaint.Receipt of this report does not change the previous investigation results.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

Evaluation summary: follow up determined that a suture was tied through the trial head.When the device was put through a trial reduction the head was lost and the suture broke when trying to pull it out.The versys trial head surgical technique does note that a suture can be used with the mis trial heads, not the trial heads that are the subject of this complaint.The mis trial heads have two holes on a flat face at the side of the heads for suture threading, however the trial head involved in this complaint only has one hole at the apex of the device.Although not proven, it is possible that the trial reduction damaged the suture and aided in the suture breaking.In general, and as stated by the email sent to inventory and operations managers on (b)(6) 2011, provisional heads may become worn from normal clinical usage potentially resulting in a loose fit over time.The field was instructed to check the mating conditions of current inventory of versys and mis provisional heads.Information was also provided regarding methods to locate a provisional head if it was lost in-vivo.The worn condition or fit with the neck trial is unknown.A host of patient factors, surgical factors, and the degree of wear of the provisional head taper may have contributed to this event, however with the information provided, a definitive root cause cannot be stated.Review of the device history records was not possible as the product and/or lot numbers required for retrieval were unavailable.

• Brand Name: VERSYS HIP PROVISIONAL FEMORAL HEAD
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; 8006136131
• MDR Report Key: 4462251
• MDR Text Key: 5319041
• Report Number: 1822565-2015-00107
• 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,distributor,health prof
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00789503205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/29/2014
• Initial Date FDA Received: 01/27/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/27/2015; 06/16/2015; 07/21/2015
• 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
• Removal/Correction Number: Z-2476-2012
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR