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

Catalog Number 00789503202

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported that after trial hip reduction, the provisional femoral head was sitting on the femoral rasp so firm that it could only be removed by striking it with the hammer.Due to this, the surgeon fears loosening of the implanted prosthesis.

Manufacturer Narrative

The femoral head provisional was returned for review.Few marks are noted on the head taper which likely happened due to the assembly and removal of the provisional head during trial reduction.Dimensions were found conforming to the print specifications where measured.The provisional head was manufactured on feb 3, 2015 and therefore have a potential field age of 1 year 9 months.Product history search for the provisional head revealed no additional complaints against the related part and lot combination.A definite root cause for the reported issue cannot be determined with the information provided.This device is used for treatment.

• Brand Name: VERSYS PROVISIONAL FEMORAL HEAD
• Type of Device: HWT
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5262142
• MDR Text Key: 32765697
• Report Number: 1822565-2015-02518
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00789503202
• Device Lot Number: 62930454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2015
• 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