MAUDE Adverse Event Report: EXACTECH, INC. NOVATION CERAMIC AHS ALUMINA LINER

Catalog Number 140-32-12

Device Problems Device Slipped (1584); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Joint Dislocation (2374); No Code Available (3191)

Event Date 07/03/2017

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Revision of hip components due to frequent subluxation.

Manufacturer Narrative

This device is used for treatment, not diagnosis.

Event Description

Patient's left hip was revised.This is one of five products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00456, 1038671-2017-00457, 1038671-2017-00458 and 1038671-2017-00460.

• Brand Name: NOVATION CERAMIC AHS ALUMINA LINER
• Type of Device: LINER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville 32653
• MDR Report Key: 6716881
• MDR Text Key: 80144747
• Report Number: 1038671-2017-00459
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• PMA/PMN Number: P050039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/22/2019

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 Expiration Date: 06/30/2019
• Device Catalogue Number: 140-32-12
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2017
• Initial Date FDA Received: 07/17/2017
• Supplement Dates Manufacturer Received: 07/07/2017
• Supplement Dates FDA Received: 01/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention