MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 3, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	07/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately five years post initial left tka, the 73 y/o female patient returned to surgeon's office with complaints of pain, swelling, instability, and dissatisfaction with their tka.The patient has a recalled implant.Upon examination, the patient was scheduled to have a revision tka possible poly swap vs full revision.Therefore, the patient underwent poly tibial insert swap and patella implant swap.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images received.Sales rep was unable to obtain x-rays.The devices are not available for evaluation as the implants were sent to the lab and legal at the hospital.
Additional Manufacturer Narrative
Section d10: concomitant products: optetrak 3 peg patella 29mm cemented (cat# 200-02-29 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2025-01603.The following sections were corrected: b5.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that a patient had a left total knee arthroplasty, approximately 4 years, 10 months after initial implant the patient had a revision surgery.Revision operative report postoperative diagnosis: failed left total knee.Patella was revised to an optetrak 3 peg patella, 32 mm diameter and a truliant polyethylene liner was placed.Patient experienced pain and swelling, imaging was consistent with possible symptomatic polyethylene wear.The polyethylene was removed and showed oxidation and mild wear.There was no loosening noted with impaction.Patient was then woken from sedation and transferred to recovery in stable condition.There was no other patient/medical information provided.No x-rays or images were provided.The device will not be returned.There is no other information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.D10 concomitants: 5486082 02-010-03-0230 - logic cr femoral cem, left, sz 3.5567501 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported via legal documentation that a patient had a left total knee arthroplasty, approximately 4 years, 10 months after initial implant the patient had a revision surgery.Revision operative report postoperative diagnosis: failed left total knee.Patella was revised to an optetrak 3 peg patella, 32 mm diameter and a truliant polyethylene liner was placed.Patient experienced pain, imaging was consistent with possible symptomatic polyethylene wear.The polyethylene was removed and showed oxidation and mild wear.There was no loosening noted with impaction.Patient was then woken from sedation and transferred to recovery in stable condition.There was no other patient/medical information provided.No x-rays or images were provided.The device will not be returned.There is no other information available.
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: a, b, c, d, e.The reason for the reported revision cannot be confirmed from the provided image but may be due to joint instability, prosthesis wear, or the inclusion of the polyethylene insert in the packaging recall.Possible causes for polyethylene damage include malalignment between implants, high contact stresses during knee flexion, patient-related conditions, inclusion of the polyethylene in the packaging recall, or any combination of these possibilities.Instability may be the result of increased soft-tissue laxity (looseness), inadequate flexion of the im-plants, or improper positioning or alignment of the prosthesis.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC TIB INSERT IMPL CRC, SZ 3, 15MM
• 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: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17586623
• Report Number: 1038671-2023-01996
• Device Sequence Number: 12023255
• Product Code: JWH
• UDI-Device Identifier: 10885862230430
• UDI-Public: 10885862230430
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/22/2025

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: 02/25/2022
• Device Model Number: N/A
• Device Catalogue Number: 02-012-51-3015
• 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: 07/26/2023
• Supplement Date Received by Manufacturer: 03/17/2025; 03/17/2025; 09/18/2025
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 03/18/2025; 03/18/2025; 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2014
• 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
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OPTETRAK LOGIC FEMORAL COMPONENT CR CEMENTED SZ 3; OPTETRAK LOGIC FIT TIBIAL TRAY CEMENTED SZ 3F/3T
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 99 KG