MAUDE Adverse Event Report: ZIMMER, INC. VERSYS HIP PROVISIONAL FEMORAL HEAD; HWT

Catalog Number 00789503203

Device Problem Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/16/2015

Event Type  Injury  

Event Description

It is reported that during surgery, the trial femoral head detached from the trial neck and became lost in the patient.The trial head remains in the patient.

Manufacturer Narrative

Evaluation summary: previous internal investigation addressed versys trial heads that are too loose and the possibility of them being lost in-vivo.In general 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.A letter was also sent to the field notifying surgeons of the issue and providing information from professional journals regarding detection of provisional heads in-vivo using such methods as ct, x-ray, and ultrasound.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 lot number required for retrieval were unavailable.Should additional substantive information be received, the complaint will be re-opened.

• Brand Name: VERSYS HIP PROVISIONAL FEMORAL HEAD
• Type of Device: HWT
• 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: 4626556
• MDR Text Key: 5656123
• Report Number: 1822565-2015-00336
• 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
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 02/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00789503203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2015
• 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-0392-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR