MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK HI-FLEX TIBIAL INSERT SZ 3 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	244-23-13
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	04/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.(d10) concomitant device(s): (b)(6) 204-40-08 - stem extension 80l x20 mm.(b)(6) 200-02-29 - three peg patella 29mm.(b)(6) 208-07-03 - cc posterior fem augment sz 3, 5mm.(b)(6) 208-09-05 - cc stem ext adaptor 5 degree.(b)(6) 208-01-03 - cc femoral sz 3.
Event or Problem Description
It was reported that this female patient was revised for a third time in (b)(6) 2021 (1st revision: case-(b)(4) / 1038671-2023-02731, 2nd revision: case-(b)(4) / 1038671-2023-02728).Polyethylene is observed with wear in the medial area and in the central pivot, with medial and posterolateral delamination.Revised to a competitor device.
Additional Manufacturer Narrative
H3: the revision reported may have been the result of malalignment between the femoral and tibial components, third body wear, patient-related conditions, the device incompatibility documented above, instability, or any combination of these possibilities, which led to wear of the polyethylene insert.However, this cannot be confirmed because the component was not returned for evaluation and images or radiographs were not provided.Additionally, the insert was packaged in a non-conforming vacuum bag for over five years, which may have contributed to the reported wear.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported may have been the result of malalignment between the femoral and tibial components, third body wear, patient-related conditions, the device incompatibility documented above, instability, or any combination of these possibilities, which led to wear of the polyethylene insert.However, this cannot be confirmed because the component was not returned for evaluation and images or radiographs were not provided.Additionally, the insert was packaged in a non-conforming vacuum bag for over five years, which may have contributed to the reported 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 3 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18103795
• Report Number: 1038671-2023-02733
• Device Sequence Number: 17499866
• Product Code: JWH
• UDI-Device Identifier: 10885862064011
• UDI-Public: 10885862064011
• 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: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2025

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: 09/22/2016
• Device Catalogue Number: 244-23-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2023
• Supplement Date Received by Manufacturer: 02/12/2024; 04/18/2025
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 02/26/2024; 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2008
• 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
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 99 KG