MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 6 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC TIBIA PS MOD INSRT SZ 6 9MM
Medical Device Problem Codes	Mechanical Problem (1384); Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); 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
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 polyethelene 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 polyethelene wear.
Additional Manufacturer Narrative
Concomitant products logic femoral ps cem left sz 6 (cat# 02-010-01-0260 / serial# (b)(4), lgc tibial fit tray cem sz 6f / 5t (cat# 02-012-45-6050 / serial# (b)(4), three peg patella 41mm (cat# 200-02-41 / serial# (b)(4), 3" drill bit, mod.Hex 2 pack (cat# 201-78-89 / serial# (b)(4), 3" drill bit, mod.Hex 2 pack (cat# 201-78-89 / serial# (b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections a2, b5, d6a, g3, g6, and h2 have been updated accordingly.Section b5: additional information received that the patient is a 71 y/o male patient.Patient complained of pain and patient had loose femur.Patient had a revision on (b)(6) 2023.There was no breakage of the device and 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 device is not available for evaluation due to recall hospital will not release.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Additional information - b3, b6, b7, & d8 h6.Investigation results-the revision reported may have been the result of reported prosthesis wear, as stated in the legal documentation, 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.These devices are used for treatment not diagnosis.There is no other information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported may have been the result of reported prosthesis wear, as stated in the legal documentation, 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.
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, e.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 TIBIA PS MOD INSRT SZ 6 9MM
• 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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15900797
• Report Number: 1038671-2022-01545
• Device Sequence Number: 17411139
• Product Code: JWH
• UDI-Device Identifier: 10885862001962
• UDI-Public: 10885862001962
• Combination Product (Y/N): N
• 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: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,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: 05/05/2022
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 6 9MM
• Device Catalogue Number: 02-012-35-6009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2022
• Supplement Date Received by Manufacturer: 01/03/2023; 06/02/2023; 02/19/2025; 04/03/2025
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 01/17/2023; 07/14/2023; 02/25/2025; 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male