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

Catalog Number 142-28-00

Device Problems Component Falling (1105); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Pain (1994); Loss of Range of Motion (2032); Joint Dislocation (2374)

Event Date 07/05/2014

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Index surgery: (b)(6) 2014.Patient presented with prosthesis luxation with posterior pain and functional limitation due to a fall.Closed reduction was performed with success.This event report was received through clinical data collection activities.

Event Description

Left hip closed reduction.This is one of five products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-00249, 1038671-2018-00250, 1038671-2018-00251, 1038671-2018-00252.

Manufacturer Narrative

This device is used for treatment not diagnosis.Corrected data: adverse event or product problem.

• Brand Name: EXACTECH FEMORAL HEAD, 12/14, COBALT CHROMIUM, 28MM OD
• Type of Device: FEMORAL HEAD
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• MDR Report Key: 6536488
• MDR Text Key: 74162283
• Report Number: 1038671-2017-00253
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K041906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/08/2019

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?: Yes
• Device Operator: Physician
• Device Catalogue Number: 142-28-00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/26/2017
• Initial Date FDA Received: 05/02/2017
• Supplement Dates Manufacturer Received: 01/08/2019
• Supplement Dates FDA Received: 01/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 79