MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 2, 9MM; SEE H10

Model Number	02-012-51-2009
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Osteolysis (2377); Joint Laxity (4526); Implant Pain (4561); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849)
Date of Event	03/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient had an initial left right total knee arthroplasty on (b)(6) 2017 and then approximately 6 years, 2 months later, on (b)(6) 2023, they experienced a revision surgery.Revision operative report of (b)(6) 2023.Postoperative diagnosis: painful right knee arthroplasty.Patient presented with pain, instability this was worsening over time.Clinical examination imaging was consistent with possible symptomatic polyethylene wear.There was no evidence of purulence.There was a small effusion, there was white synovitis involving the knee which can be seen with poly wear.No loosening/instability of the femoral or tibial components.There was a small amount of osteolysis evident along the lateral margin of the femur.There was significant wear involving the anterior aspect of the patella.There was enough wear of the patella that it could potentially cause some particle disease.Patella component was revised.Sterile dressing was applied, and the patient was transferred to recovery instable condition.Patient will follow up with orthopedic clinic 2 weeks post op.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
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.D10.Concomitants: 3971218 200-05-26 - inset patella 26mm.4207918 02-012-45-2030 - lgc tibial fit tray cem sz 2f / 3t.4575936 02-010-03-0320 - logic cr femoral cem, right, sz 2.Pending investigation.No other information is available.
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 and instability 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 TIB INSERT IMPL CRC, SZ 2, 9MM
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 17109289
• Report Number: 1038671-2023-01321
• Device Sequence Number: 6260014
• Product Code: JWH
• UDI-Device Identifier: 10885862230324
• UDI-Public: 10885862230324
• 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: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2025

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: 01/06/2022
• Device Model Number: 02-012-51-2009
• Device Catalogue Number: 02-012-51-2009
• 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: 05/11/2023
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2014
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown