MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 9MM

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 09/27/2022

Event Type  Injury  

Event Description

As reported by the legal brief, before (b)(6) 2013, patient began medical treatment left knee arthritis.Before (b)(6) 2013, the orthopaedic surgeon indicated that the patient met the criteria for a total knee replacement on his left knee.On or about (b)(6) 2013, surgeon implanted the recalled optetrak components into patient's left knee.On or about (b)(6) 2022, patient underwent surgery to remove the optetrak 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

Concomitant medical products: logic femoral ps cem left sz 5 (cat# 02-010-01-0250 / serial# (b)(4)).One peg patella 35mm (cat# 200-03-35 / serial# (b)(4)).Lgc tibial fit tray cem sz 5f / 4t (cat# 02-012-45-5040 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Manufacturer Narrative

(h3) as reported by the legal brief, before on (b)(6) 2013, patient began medical treatment left knee arthritis.Before on (b)(6) 2013, the orthopaedic surgeon indicated that the patient met the criteria for a total knee replacement on his left knee.On or about on (b)(6) 2013, surgeon implanted the recalled optetrak components into patient's left knee.On or about on (b)(6) 2022, patient underwent surgery to remove the optetrak 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 5, 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: 16208189
• MDR Text Key: 307723001
• Report Number: 1038671-2023-00049
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862173713
• UDI-Public: 10885862173713
• 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: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2020
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 9MM
• Device Catalogue Number: 02-012-44-5009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2012
• 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: Male