MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC FEMORAL COMPONENT POSTERIOR STABILIZED, CEMENTED

Catalog Number 02-010-01-0220

Event Date 06/20/2016

Event Type  Injury  

Event Description

Index surgery:(b)(6) 2014. Revision of left knee due to aseptic loosening.

Manufacturer Narrative

Engineering evaluation noted that the revision reported was likely the result of aseptic (non-infected) loosening, which damaged the bond of the implant to the bone.

Event Description

Index surgery: (b)(6) 2014. Revision of left knee due to aseptic loosening.

• Brand Name: OPTETRAK LOGIC FEMORAL COMPONENT POSTERIOR STABILIZED, CEMENTED
• Type of Device: FEMORAL COMPONENT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66th ct; gainesville , FL 32653
• MDR Report Key: 6681253
• Report Number: 1038671-2017-00428
• Device Sequence Number: 1
• Product Code: JWH
• Report Source: Manufacturer
• Source Type: HEALTH PROFESSIONAL
• Reporter Occupation: ATTORNEY
• Type of Report: Initial,Followup
• Report Date: 06/01/2018

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 06/30/2017
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No

Device Operator

• Device Catalogue Number: 02-010-01-0220
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 06/20/2017
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 06/30/2017 Patient Sequence Number: 1