MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 13MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377)
Date of Event	04/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 02-010-01-0240 - logic femoral ps cem left sz 4, (b)(6); 02-012-45-4030 - lgc tibial fit tray cem sz 4f / 3t, (b)(6); 200-07-35 - advanced patella 35mm 3 peg implant, (b)(6); 204-34-04 - fluted stem extension 40l x 14 mm, (b)(6); 204-70-00 - tibial stem ext.Screw, (b)(6); a10012 - gps implant kit v2, (b)(6).Pending investigation.
Event or Problem Description
As reported via legal documentation the male patient had a left knee replacement on (b)(6) 2017.Approximately 6 years and 3 months after the initial procedure the patient had a left knee revision on (b)(6) 2023.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Revision op report on (b)(6) 2023 diagnosis: painful left knee replacement with osteolysis it was noted that the polyethylene insert had some wear on the post and medial aspect.The tibial tray despite extensive osteolysis was well fixed.The patient was awakened, moved to the stretcher and taken to the recovery room in satisfactory condition.There were no immediate complications.
Additional Manufacturer Narrative
The revision reported was likely the result of prosthesis wear and osteolysis.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The extent and root cause of the prosthesis wear and osteolysis could not be determined as the devices were not returned for evaluation, and images and radiographs were not provided.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: matt collins ; 3523771140
• MDR Report Key: 17333415
• Report Number: 1038671-2023-01676
• Device Sequence Number: 12423836
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2026

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: 07/24/2020
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 13MM
• Device Catalogue Number: 02-012-44-4013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 04/11/2024; 09/24/2026
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 04/18/2024; 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2012
• 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: A
• 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 Age: 73 YR
• Patient Sex: Male