MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 2.5, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	SPECIFIC DEVICE NOT REPORTED
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Synovitis (2094); Joint Laxity (4526); Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	06/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a right knee replacement on (b)(6) 2015.Approximately 6 years and 11 months after the initial procedure the patient had a right knee revision on (b)(6) 2022.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Event or Problem Description
It was reported via legal documentation that approximately 83 months after a right total knee replacement procedure, the patient underwent a revision procedure to address polyethylene wear, pain, significant swelling with any activity, and instability.Revision surgery operative notes were provided.Pre-operative and post-operative diagnoses indicated failed right total knee replacement secondary to accelerated wear of the tibial polyethylene bearing surface.Findings noted moderate to severe synovitis occupying the suprapatellar ouch with an expanded synovial membrane consistent with foreign body reaction.There was no evidence of infection.The femoral, tibial, and patella components were all extremely well fixed.The tibial polyethylene showed surface pitting and abrasive wear with evidence of delamination.The surgeon performed a revision right total knee replacement, polyethylene exchange.The patient was taken to the recovery room in stable condition.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.Health effect - component code, h8.D10: (b)(6) - 02-010-01-0325 - logic femoral ps cem right sz 2.5.(b)(6) - 02-012-41-2515 - logic tibia traptray cem sz 2.5f/1.5t.(b)(6) - 200-02-32 - three peg patella 32mm.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c, d, g.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and instability or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 2.5, 11MM
• 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: kate jacobson ; 3523771140
• MDR Report Key: 16884761
• Report Number: 1038671-2023-00914
• Device Sequence Number: 15034432
• Product Code: JWH
• UDI-Device Identifier: 10885862173522
• UDI-Public: 10885862173522
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2025

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: 04/11/2022
• Device Model Number: SPECIFIC DEVICE NOT REPORTED
• Device Catalogue Number: 02-012-44-2511
• 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: 04/14/2023
• Supplement Date Received by Manufacturer: 07/14/2023; 05/09/2025
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 03/25/2025; 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2014
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female