MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH FEMORAL HEAD, 12/14, BIOLOX FORTÉ (ALUMINA), 36MM OD

Catalog Number 140-36-03

Device Problems Crack (1135); Fracture (1260); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Joint Disorder (2373); No Code Available (3191)

Event Date 05/19/2017

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2014.Revision due to fractured liner.

Manufacturer Narrative

Engineering evaluation noted that the revision was likely the result of fracture of the insert.The patient's job as a laborer, and the associated heavy lifting may have contributed to the fracture but no truma was reported.Due to the missing fragments and secondary damages, a conclusion cannot be drawn regarding a possible cause for the fracture of the insert.

Event Description

Index surgery: (b)(6) 2014.Revision due to fractured liner.

Manufacturer Narrative

The revision reported in this event was likely the result of fracture of the insert.The patient's job as a laborer, and the associated heavy lifting may have contributed to the fracture, but no trauma was reported.Due to the missing fragments and secondary damages, a conclusion cannot be drawn regarding a possible cause for the fracture of the insert this device is used for treatment, not diagnosis corrected data: occupation: health professional.

Event Description

It was reported that a patient experienced a surgical revision procedure of hip components due to a fractured ceramic liner.The initial hip surgery date is (b)(6) 2014.The patient works as a laborer and cannot recall any trauma.Weakness was felt in the hip.Information was requested, and no additional information was provided.This is one of two products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00304 and 1038671-2017-00567.

• Brand Name: EXACTECH FEMORAL HEAD, 12/14, BIOLOX FORTÉ (ALUMINA), 36MM OD
• Type of Device: FEMORAL HEAD
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 6774125
• MDR Text Key: 82056214
• Report Number: 1038671-2017-00567
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2019

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: Health Professional
• Device Expiration Date: 03/12/2019
• Device Catalogue Number: 140-36-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/12/2017
• Initial Date FDA Received: 08/08/2017
• Supplement Dates Manufacturer Received: 05/12/2017; 02/20/2019
• Supplement Dates FDA Received: 10/02/2018; 02/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention