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

Model Number	LOGIC CR TIB INSERT SLOPE +. SZ 3.5, 9 MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer d10: concomitants: 4416750 - 02-010-04-0235 - logic cr femoral por, left, sz 3.5.4080263 - 02-012-45-3545 - lgc tibial fit tray cem sz 3.5f / 4.5t.3703080 - 200-02-41 - three peg patella 41mm.4923664 - 201-78-15 - holding pin mini sharp point 4 pk.4857175 - 201-78-81 - 3 trocar, mod.Hex 2pk.4579991 - 521-78-23 - threaded pin size 2.3 collared.4976635 - 521-78-23 - threaded pin size 2.3 collared.4576029 - 521-78-32 - threaded pin size 3.0 collarless.6000017119 - a10012 - gps implant kit v2.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a 74 yo male patient, initial left knee implanted on (b)(6) 2017, underwent a revision procedure on (b)(6) 2024, approximately 6 years 4 months post the initial procedure.The patient was revised due to poly and patella wear and femoral loosening.The tibial insert was revised to size 3.5, 11mm.The femoral component was revised to size 3.5.There was no device breakages or surgical delays during the procedure.X-rays were provided.The patient was last known to be in stable condition following the event.No device returns available as the hospital disposed of them.Device images were provided.No further information.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of prosthesis wear and an insufficient bond between the femoral component and the bone, which led to aseptic (non-infected) femoral loosening.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 and femoral loosening could not be determined as the devices were not returned for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6, h11 no device was returned for evaluation; photographs of the device and radiograph images were provided; however, the reported event was unable to be confirmed.Operative notes and/or medical records were not provided for review of usage/ technique.A review of manufacturing data was performed and no discrepancies relevant to the reported event were found.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, may have resulted from an insufficient bond between the femoral component and the bone, malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: OPTETRAK 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: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18813195
• Report Number: 1038671-2024-00363
• Device Sequence Number: 8271597
• Product Code: JWH
• UDI-Device Identifier: 10885862159281
• UDI-Public: 10885862159281
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/10/2023
• Device Model Number: LOGIC CR TIB INSERT SLOPE +. SZ 3.5, 9 MM
• Device Catalogue Number: 02-012-48-3509
• 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: Not provided
• Supplement Date Received by Manufacturer: 05/13/2024; 11/07/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 05/30/2024; 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2015
• 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: 74 YR
• Patient Sex: Male