MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Catalog Number 02-012-44-2015

Device Problem Fitting Problem (2183)

Patient Problem Failure of Implant (1924)

Event Date 01/01/2016

Event Type  Injury  

Event Description

It was reported via clinical study, that the 65 yo female patient experienced aseptic femoral loosening with persistent thigh pain related to micromotion of femoral stem with incomplete fixation.The date of adverse event onset is unk-unk-2016.Initially tried strengthening exercises as patient treatment.The patient was revised on (b)(6) 2021 along with medication.The patient¿s outcome was last known as resolved on (b)(6) 2021.

Manufacturer Narrative

Concomitant medical products: 02-010-06-0220 - 4114527 - logic cc femoral size 2, left.02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t.02-012-60-1680 - logic stem ext 16mm x 80mm.208-05-02 - cc distal fem augment sz 2, 5mm.

• Brand Name: OPTETRAK LOGIC
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16844502
• MDR Text Key: 314294672
• Report Number: 1038671-2023-00514
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862173508
• UDI-Public: 10885862173508
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 01/03/2020
• Device Catalogue Number: 02-012-44-2015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2012
• 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): Other; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Race: White