MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 15MM; SEE H10

Model Number	02-012-44-3015
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	01/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient had a left total knee arthroplasty revision on (b)(6) 2011 and then approximately 11 years, 1 month later on 16 (b)(6)2023 the patient experienced a second revision surgical procedure.The patient was revised to an exactech device.Revision operative report of (b)(6) 2023-post operative diagnosis: failed left total knee replacement secondary to wear of the bearing surface.Findings: patient was doing well and noticed increasing pain, instability, and chronic dramatic swelling of the knee that was made worse after exercise or prolonged walking.Patient received a recall letter.In (b)(6) of 2022 severe massive chronic synovitis a large synovial effusion was noted.The synovial effusion showed a predominance of monocytes and macrophages consistent with polyethylene wear and he was diagnosed as having accelerated polyethylene wear due to oxidation of the polyethylene component.Upon entering the knee, massive synovitis was noted.The femoral, tibial, and patellar components were all well fixed and there was extreme severe erosion, delamination and breakdown of the tibial polyethylene insert.A new truliant insert was implanted.Dressings were applied, the patient was awakened and taken to the recovery room in stable condition.No complications during the procedure.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.These devices are used for treatment not diagnosis.Pending investigation.There is no other information available.
Additional Manufacturer Narrative
Investigation results - the revision reported in (b)(4) was likely the result of prosthesis wear.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The extent and root cause of the prosthesis wear could not be confirmed as the device was not returned for evaluation, and images and radiographs were not provided.These devices are used for treatments, not diagnosis.There is no other information available.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 15MM
• 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: michael crader
• MDR Report Key: 17258779
• Report Number: 1038671-2023-01543
• Device Sequence Number: 18157857
• Product Code: JWH
• UDI-Device Identifier: 10885862173584
• UDI-Public: 10885862173584
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2024

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: 07/13/2019
• Device Model Number: 02-012-44-3015
• Device Catalogue Number: 02-012-44-3015
• 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: 06/06/2023
• Supplement Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2011
• 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: 61 YR
• Patient Sex: Male