MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 11MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a male patient, who had their right knee initially implanted on (b)(6) 2014, was brought back for right knee pain approximately 7 years 10 months the initial implant procedure.The poly was removed with significant wear.The tibia was found to be loose and removed as well.The patient received a truliant 4/3 tibial tray, 13mm stem, a stem extension screw, and a new size 15mm ps high flex insert.Patient was last known to be in stable condition following the event.No device returning as the patient has requested the implants.
Additional Manufacturer Narrative
Device available for evaluation: no device return anticipated as the patient requested the devices.Concomitants: 02-012-45-4030 lgc tibial fit tray cem sz 4f / 3t k101981.Recall: z-2112 thru 2133-2021.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
The revision reported was likely the result of both prosthesis wear and tibial loosening.The prosthesis wear may have been the result of excessive posterior slope of the tibial tray, malalignment between the femoral and tibial components, third body wear, instability, patient-related conditions, or any combination of these possibilities.An additional contributing factor to the tibial insert damage may have been the result of being packaged in a non-conforming vacuum bag for more than five years.The aseptic (non-infected) tibial loosening may have been the result of an insufficient bond between the tibial tray and the bone.However, this cannot be confirmed as the devices were not returned for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.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.A definitive root cause was unable to be determined; however, the prosthesis wear may have been the result of excessive posterior slope of the tibial tray, malalignment between the femoral and tibial components, third body wear, instability, patient-related conditions, or any combination of these possibilities.An additional contributing factor to the tibial insert damage may have been the result of being packaged in a non-conforming vacuum bag for more than five years.The aseptic (non-infected) tibial loosening may have been the result of an insufficient bond between the tibial tray and the bone.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 4 11MM
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15292813
• Report Number: 1038671-2022-00964
• Device Sequence Number: 7091978
• Product Code: JWH
• UDI-Device Identifier: 10885862064042
• UDI-Public: 10885862064042
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2026

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: 02/17/2017
• Device Model Number: OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 11MM
• Device Catalogue Number: 244-24-11
• 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: 07/29/2022
• Supplement Date Received by Manufacturer: 05/19/2023; 04/16/2026
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 05/30/2023; 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2009
• 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; Hospitalization
• Patient Sex: Male