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
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/27/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 1038671-2023-00049
• Device Sequence Number: 20179095
• Product Code: JWH
• UDI-Device Identifier: 10885862173713
• UDI-Public: 10885862173713
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2023

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?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male