MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 5 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-5011
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849)
Date of Event	10/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 7.5 years right tka, the 62 y/o male patient complained of pain.Patient had a loose femur and recalled poly.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.X-ray and image received.The devices are nor available for evaluation due to hospital will not release.Recall implants.It was reported via legal documentation that the patient underwent a bilateral total knee replacement surgery and was implanted with an optetrak device.The patient began experiencing pain, swelling, clicking, popping, and unsteadiness in both knees.His knees would also feel hot to the touch.The patient visited his physician for an annual follow-up appointment regarding his knee replacements.He reported pain, swelling, clicking, popping, sensations of looseness, difficulty ascending and descending stairs, and issues moving from a seated to standing position.The physician also noted bilateral knee effusion and recommended aspiration of the knee followed by revision surgery if the aspiration revealed no infection in the knee.There is no other patient demographic or medical history available.No additional information is available.
Additional Manufacturer Narrative
Related: mfr #1038671-2023-00758 report 1 of 2.H11.Additional manufacturer narrative- report 2 of 2.D10.Concomitants: 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t three peg patella.These devices are used for treatment not diagnosis.There is no additional information available.Pending investigation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported may be the result of prosthesis wear.Additional reasons for the reported revision may be femoral loosening, instability, or due to inclusion of the polyethylene in the packaging recall.However, the reported femoral loosening and instability could not be confirmed from the provided information.Potential contributions of user-related considerations to the event could not be assessed as the devices were not available for evaluation and relevant clinical information 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 PS MOD INSRT SZ 5 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19596777
• Report Number: 1038671-2024-02088
• Device Sequence Number: 8493738
• Product Code: JWH
• UDI-Device Identifier: 10885862001931
• UDI-Public: 10885862001931
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/18/2022
• Device Catalogue Number: 02-012-35-5011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male