MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM LEFT SZ 6; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LOGIC FEMORAL PS CEM LEFT SZ 6
Medical Device Problem Codes	Mechanical Problem (1384); Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	01/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.D10 concomitants: lgc tibial fit tray cem sz 6f / 5t (cat# 02-012-45-6050 / serial# (b)(6), three peg patella 41mm (cat# 200-02-41 / serial# (b)(6), 3" drill bit, mod.Hex 2 pack (cat# 201-78-89 / serial# (b)(6), 3" drill bit, mod.Hex 2 pack (cat# 201-78-89 / serial# (b)(6).
Event or Problem Description
As reported by legal brief, on (b)(6) 2017, patient underwent a left knee replacement surgery and was implanted with an optetrak device.In (b)(6) 2019, a bone scan revealed stress shielding and posterior and superior femoral effusion.Patient was diagnosed with continued pain in left knee and continued effusion of left knee.Thus, due to worsening pain, effusion, chronic synovitis, swelling, loss of range of motion, left foot drop, and findings of ¿radiographs and physical exam of left total knee arthroscopy are consistent with polyethylene wear¿, patient is scheduled for a left knee replacement revision surgery in (b)(6) 2023 to remove the defective optetrak device.Upon information and belief, the effusions, synovitis, swelling, pain, and limited range of motion are due to polyethylene wear.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, loss of range of motion, and femoral loosening.The femoral loosening may have been the result of an insufficient bond between the femoral component and the bone.The reported prosthesis wear cannot be confirmed as the device was not returned for evaluation and the photographed insert does not appear to show signs of wear that are inconsistent with being implanted for 5.5 years.An additional contributing factor to the revision may have been inclusion of the implanted polyethylene component in the packaging recall.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC FEMORAL PS CEM LEFT SZ 6
• 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21426348
• Report Number: 1038671-2025-01120
• Device Sequence Number: 15417584
• Product Code: JWH
• UDI-Device Identifier: 10885862001184
• UDI-Public: 10885862001184
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2025

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: 09/20/2021
• Device Model Number: LOGIC FEMORAL PS CEM LEFT SZ 6
• Device Catalogue Number: 02-010-01-0260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/03/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2023
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 04/04/2025
• Date Device Manufactured: 09/21/2016
• 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; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male