MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 4 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	LOGIC TIBIA PS MOD INSRT SZ 4 13MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Cyst(s) (1800); Pain (1994); Synovitis (2094); Osteolysis (2377); Joint Laxity (4526); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	11/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 02-010-01-0240 - logic femoral ps cem left sz 4; (b)(6), 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t; (b)(6), 200-02-38 - three peg patella 38mm; (b)(6), 204-34-02 - fluted stem extension 25l x 14 mm; (b)(6), 204-70-00 - tibial stem ext.Screw.Pending investigation.
Event or Problem Description
As reported via legal documentation that a 56 y/o male patient had a left knee replacement on (b)(6) 2015.Approximately 7 years after the initial procedure the patient had a left knee revision on (b)(6) 2022.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) 2022.Postop diagnosis: failed left total knee arthroplasty with polyethylene insert wear, aseptic femoral component loosening with severe underlying osteolysis, global instability.Patient had increasing pain, swelling and instability.Findings: a marked effusion was noted.A large effusion was present within the knee with normal-appearing joint fluid.The knee synovium was markedly thickened and contained copious amount of bead-like projections with a whitish-gray hue consistent with pronounced particle disease.The indwelling polyethylene insert exhibited mild macroscopic poly wear.The femoral component was found to be grossly loose and readily explanted.The femoral component was completely debonded from the underlying cement.Upon removing the cement off of the distal femur, a massive cystic osteolytic lesion was present involving nearly the entirety of the lateral femoral condyle and the notch with only the cortical rim of the lateral condyle still intact.The tibial baseplate was vigorously tested and confirmed to be still will-fixed to bone.The patellar button was also still well fixed without any obvious signs of macroscopic wear.Collaterals and the extensor mechanism were intact.A silverlon dressing was applied.The patient was awoken and transferred to the pacu in stable condition.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3/g4, h6 the following sections were corrected: d1/d2a/d2b, h6 mdr section codes updated/corrected: a, b, c, d, e, g the reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, and femoral loosening 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 PS MOD INSRT 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: kate jacobson ; 3523771140
• MDR Report Key: 17305123
• Report Number: 1038671-2023-01618
• Device Sequence Number: 17768743
• Product Code: JWH
• UDI-Device Identifier: 10885862001900
• UDI-Public: 10885862001900
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• 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
• Report Date (Section B): 01/22/2025

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: 03/01/2021
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 4 13MM
• Device Catalogue Number: 02-012-35-4013
• 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: 06/12/2023
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2013
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male