MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK HI-FLEX TIBIAL INSERT SZ 5 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	244-25-09
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	03/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.H7: z-0019-2022.
Event or Problem Description
During the week of (b)(6), 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 244-25-09-inserto tib ps hi-flex 5, 9mm, serial number (b)(6) on (b)(6)2013.The insert was manufactured on 10/17/2011 and was packaged in a vacuum bag with no evoh.The insert was manufactured on 10/17/2011 and was 1.3689253935660506 years shelf age at the time of implant.On (b)(6)2022, approximately 9.0 years post implantation, the patient underwent revision for wear of the polyethylene.No additional details are available at this time.
Additional Manufacturer Narrative
H3: the revision reported may have been due to third body wear, patient-related conditions, instability, and/or malalignment between the femoral and tibial components, which led to prosthesis wear.However, this cannot be confirmed as the device was not available for evaluation and images of the explanted device/radiographs were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported may have been due to third body wear, patient-related conditions, instability, and/or malalignment between the femoral and tibial components, which led to prosthesis wear.However, this cannot be confirmed as the device was not available for evaluation and images of the explanted device/radiographs were not provided.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 5 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16953076
• Report Number: 1038671-2023-01015
• Device Sequence Number: 15182466
• Product Code: JWH
• UDI-Device Identifier: 10885862064073
• UDI-Public: 10885862064073
• 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: 2013
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2025

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: 10/17/2019
• Device Model Number: 244-25-09
• Device Catalogue Number: 244-25-09
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/28/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Supplement Date Received by Manufacturer: 07/21/2023; 04/17/2025
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 07/26/2023; 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2011
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown