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

Model Number	CR TIBIAL INSERT SZ4, 13MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer d10: concomittants: 02-012-45-4050 - bandeja tibial logic fit 4f/5t 3798133.200-02-35 - rotula tres tetones 35mm 3596964.232-02-04 - comp.Femoral asimetrico poroso cr nº4 izq 2842942.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
Ubarmin #43 during the week of april 17-25, representatives of exactech, inc.And exactech spain conducted an inperson site visit with (b)(6) hospital.As a result of that site visit and at exactech's request, the hospital provided a retrospective excel listing of revision related to polyethylene wear that have been performed since 2010.These cases have not previously been reported to exactech as complaints.This patient ((b)(6)) was implanted with a 200-24-13-inserto tib cr 4, 13mm, serial number (b)(6)on 2/25/2015.The insert was manufactured on 6/5/2010 and was packaged in a vacuum bag with no evoh.The insert was manufactured on 6/5/2010 and was 4.7 years shelf age at the time of implant.Revision pending for wear of the polyethylene.No additional details are available at this time.
Additional Manufacturer Narrative
H3: the prosthesis wear reported may have been due to third body wear, patient-related conditions, instability, and/or malalignment between the femoral and tibial components.However, this cannot be confirmed as the device was not available for evaluation and radiographs were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b3, d6b, h6 - health effect - impact code, investigation findings, investigation conclusion, h7 and h11.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A definitive root cause was unable to be determined; however, may have resulted from third body wear, patient-related conditions, instability, and/or malalignment between the femoral and tibial components, which led to prosthesis wear.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: OPTETRAK
• 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: 16988692
• Report Number: 1038671-2023-01095
• Device Sequence Number: 17855685
• Product Code: JWH
• UDI-Device Identifier: 10885862040312
• UDI-Public: 10885862040312
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K932776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2026

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: 06/05/2018
• Device Model Number: CR TIBIAL INSERT SZ4, 13MM
• Device Catalogue Number: 200-24-13
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Supplement Date Received by Manufacturer: 07/18/2023; 03/28/2026
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 08/08/2023; 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2010
• 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-0019-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Sex: Unknown