MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK HI-FLEX TIBIAL INSERT, SZ 2, 11MM; SEE H10

Model Number	OPTETRAK HI-FLEX TIBIAL INSERT, SZ 2, 11MM
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
Event or Problem Description
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 244-22-11-inserto tib ps hi-flex 2, 11mm, serial number (b)(6) on (b)(6)2012.The insert was manufactured on 2/4/2011 and was packaged in a vacuum bag with no evoh.The insert was manufactured on 2/4/2011 and was 0.95550992470910334 years shelf age at the time of implant.Pending revision for wear of the polyethylene.No additional details are available at this time.
Additional Manufacturer Narrative
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.D10: concomittants: 204-04-23 - bandeja tib quilla trap cementada 1f/3t, 2f/3t 2095551.204-34-04 - vastago ext.14x40mm 1903080.204-70-00 - tornillo fijacion vástago a tibia 2149142.244-02-02 - comp.Femoral asimetrico cementado hf ps nº2 izq.2073378.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H6: the prosthesis wear reported may have been due to third body wear, patient-related conditions, instability, malalignment between the femoral and tibial components, and/or being implanted for over 11 years.However, this cannot be confirmed as the devices were 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, type of investigation, 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 HI-FLEX TIBIAL INSERT, SZ 2, 11MM
• 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: 16988863
• Report Number: 1038671-2023-01096
• Device Sequence Number: 17860493
• Product Code: JWH
• UDI-Device Identifier: 10885862063960
• UDI-Public: 10885862063960
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• 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: 02/03/2019
• Device Model Number: OPTETRAK HI-FLEX TIBIAL INSERT, SZ 2, 11MM
• Device Catalogue Number: 244-22-11
• 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: 06/30/2023; 03/28/2026
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 07/17/2023; 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2011
• 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-0019-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Sex: Unknown