MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 2.5 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LOGIC TIBIA PS MOD INSRT SZ 2.5 11MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Emotional Changes (1831); Pain (1994); Scar Tissue (2060); Synovitis (2094); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849)
Date of Event	03/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer,metal,polymer.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported via a legal notification, that a patient, initial right knee implanted on (b)(6) 2012, with an optetrak device, including an insert made of polyethylene, will undergo a revision procedure on (b)(6) 2023.As a result of defendants¿ failure to properly package the optetrak device prior to distribution, the polyethylene liner prematurely degraded and plaintiff will be required to undergo revision surgery due to severe pain, swelling, and instability in the knee and leg.These injuries were caused by early and preventable wear of the polyethylene insert and resulting component loosening and/or other failures causing serious complications including tissue damage, osteolysis, permanent bone loss and other injuries.No further information.
Event or Problem Description
Additional information via legal department-the patient was revised to competitor's devices.Revision op report on (b)(6) 2023 diagnosis: 1.Instability after total knee replacement, 2.Recalled knee replacement 3.Osteolysis/synovitis.Revision of right total knee, both components.Findings: intraoperatively there was a large effusion, there was significant synovitis throughout the suprapatellar pouch medial and lateral gutters.The polyethylene was noted to be worn and oxidized.The tibial and femoral component were found to be well fixed-they were removed.The devices were trailed and then implanted.There were no surgical complications.The patient was transferred to the recovery room in stable condition.Hospital care time-admitted (b)(6) 2023, discharged on (b)(6) 2023.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.
Additional Manufacturer Narrative
D10.Femoral logic (2111758); tray tibia (1836637); patella (2300661).H6.Investigation results-the revision reported may have been the result of polyethylene wear, osteolysis, and instability as stated in the legal documentation and operative notes.The extent and root cause of the reported polyethylene wear and osteolysis cannot be determined as the devices were not available for evaluation and pre-revision radiographs and images of the explanted devices were not provided.These devices are used for treatment not diagnosis.There is no other information available.B3 the device was revised.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and instability or due to inclusion of the polyethylene in the packaging recall.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.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 2.5 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16449211
• Report Number: 1038671-2023-00263
• Device Sequence Number: 14911578
• Product Code: JWH
• UDI-Device Identifier: 10885862001771
• UDI-Public: 10885862001771
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/06/2025

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: 05/02/2015
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 2.5 11MM
• Device Catalogue Number: 02-012-35-2511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2023
• Supplement Date Received by Manufacturer: 07/28/2023; 02/27/2025; 03/04/2025
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 08/21/2023; 03/03/2025; 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2010
• 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: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female