MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH FEMORAL HEAD, 12/14, ZIRAMIC ZIRCONIA, 28MM OD

Catalog Number 148-28-00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 01/23/2017

Event Type  Injury  

Manufacturer Narrative

The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.Pending evaluation.

Event Description

Index surgery: (b)(6) 2012.Revision of left hip due to acetabular asymmetry.The case report indicates this event is unlikely related to devices and definitely related to procedure.This event report was received through clinical data collection activities.

Manufacturer Narrative

Note: upon review it was found that this event and this device was reported in mfr:1038671-2016-00422, all information will continue to updated in that mfr as required.This device is used for treatment, not diagnosis.

Event Description

This is one of two products involved with the reported event and the associated manufacturer report number is 1038671-2017-00938.

• Brand Name: EXACTECH FEMORAL HEAD, 12/14, ZIRAMIC ZIRCONIA, 28MM OD
• Type of Device: FEMORAL HEAD
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7153965
• MDR Text Key: 96019478
• Report Number: 1038671-2017-00939
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/15/2019

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: Physician
• Device Catalogue Number: 148-28-00
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2017
• Initial Date FDA Received: 12/29/2017
• Supplement Dates Manufacturer Received: 03/15/2019
• Supplement Dates FDA Received: 03/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Weight: 78