MAUDE Adverse Event Report: EXACTECH, INC. LOGIC; SEE H10

Model Number	LOGIC CR TIB INSERT STD, SZ 3.5, 9 MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	10/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Prosthesis, knee, patellofemoral, semi-constrained, cemented, polymer/metal/polymer.Concomitants: 4255980 02-010-03-0235 - logic cr femoral cem, left, sz 3.5.5507795 02-012-45-3535 - lgc tibial fit tray cem sz 3.5f / 3.5t.2516333 02-012-47-3509 - logic cr tib insert std, sz 3.5, 9 mm.5623160 200-02-32 - three peg patella 32mm.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 left knee replacement, implanted with an optetrak device, including an insert made of polyethylene, on (b)(6) 2018, underwent a revision procedure on (b)(6) 2022, approximately 4 years i month post the initial procedure.As a direct, proximate and legal consequence of the defective nature of the optetrak device as described herein, the plaintiff has suffered and continues to suffer permanent and debilitating injures and damages, including but not limited to, significant pain and discomfort; gait impairment; poor balance; difficulty walking; component part loosening; soft tissue damage; bone loss; and other injuries presently undiagnosed, which all require ongoing medical care.As a further direct, proximate and legal consequence of the defective nature of the optetrak device, the plaintiff has sustained and will sustain future damages, including but not limited to cost of medical care; rehabilitation; home health care; loss of earning capacity; mental and emotional distress; loss of consortium and pain and suffering.No device returns anticipated due to this being a legal case.No further information.
Additional Manufacturer Narrative
H3.Investigation results: based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined; however, it is most likely related to the report of pain.There is no other patient medical history available.These devices are used for treatment not diagnosis.Additional information: h6 investigation codes.
Event or Problem Description
Poly swap - recalled poly.Reported event was not related to breakage of a device and did not lead to surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images and x-rays unavailable.This is 1 of 2 reports for this event.

• Brand Name: LOGIC
• Common Device Name: SEE H10
• 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: 16464238
• Report Number: 1038671-2023-00315
• Device Sequence Number: 2454630
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/23/2026

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: 11/05/2020
• Device Model Number: LOGIC CR TIB INSERT STD, SZ 3.5, 9 MM
• Device Catalogue Number: 02-012-47-3509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2023
• Supplement Date Received by Manufacturer: 03/27/2023; 06/17/2026
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 03/28/2023; 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2013
• 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: 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; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male