MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 01/24/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: logic tibia traptray cem sz 4f/4t (cat# 02-012-41-4040 / serial# (b)(4)); one peg patella 32mm (cat# 200-03-32 / serial# (b)(4)); logic femoral ps cem right sz 4 (cat# 02-010-01-0340 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported by legal team, before (b)(6) 2013, patient began medical treatment right knee arthritis.On or about (b)(6) 2013, surgeon implanted the exactech optetrak into the right knee of patient.On or about (b)(6) 2022, patient underwent surgery to remove the optetrak.Surgeon removed the right side optetrak implant from patient and replaced it with another implant on or about (b)(6) 2022, surgeon found that the recalled optetrak polyethylene failed.No other patient/medical information provided.

Manufacturer Narrative

(h3) as reported by legal team, before on (b)(6) 2013, patient began medical treatment right knee arthritis.On or about on (b)(6) 2013, surgeon implanted the exactech optetrak into the right knee of patient.On or about on (b)(6) 2022, patient underwent surgery to remove the optetrak.Surgeon removed the right side optetrak implant from patient and replaced it with another implant.On or about on (b)(6) 2022, surgeon found that the recalled optetrak polyethylene failed.No other patient/medical information provided.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16224461
• MDR Text Key: 307907979
• Report Number: 1038671-2023-00057
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862173638
• UDI-Public: 10885862173638
• 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: Other,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2020
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM
• Device Catalogue Number: 02-012-44-4009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0021-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female