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

Model Number	244-03-04
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Unspecified Musculoskeletal problem (4535)
Date of Event	03/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 4 years post op the initial right tka, this male patient was revised due to implant loosening bone loss and significant synovitis.Patient had been complaining of mechanical complications and chronic pain.
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t, 2921769; 200-02-35 - three peg patella 35mm, 4271300; 244-24-11 - optetrak hi-flex tibial insert sz 4 11mm, 1384194.
Additional Manufacturer Narrative
H6: investigation results - the revision reported was likely the result of prosthesis wear and osteolysis.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.It is possible that a contributing factor to the reported wear may have been the result of being packaged in a non-conforming bag for more than 5 years before it was implanted.The extent and root cause of the prosthesis wear and osteolysis could not be determined as the devices were not returned for evaluation, and images and radiographs were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: a2, b4.The following sections were corrected: b1, b2, d1, d4, d8, h3, h4, h6 - health effect - clinical code, medical device problem code, component code, type of investigation, investigation findings and h11.The revision reported was likely the result of prosthesis wear and osteolysis.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.It is possible that a contributing factor to the reported wear may have been the result of being packaged in a non-conforming bag for more than 5 years before it was implanted.The extent and root cause of the prosthesis wear and osteolysis could not be determined as the devices were not returned for evaluation, and images and 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.
Event or Problem Description
Per the right knee revision operative report, the patient was diagnosed with ¿osteolysis.¿ there was a massive amount of synovitis in the knee.Tissue was sent and this was negative for acute inflammation.The description of the operation noted that ¿the patellar component was well fixed.The femur and tibia were both well fixed but had a massive underlying osteolysis.¿ the operative note also states that there was ¿bony degeneration from poly wear.¿ the patient was taken to the recovery room having tolerated the procedure without complications.No further impact to the patient was reported.No additional information is available.

• Brand Name: OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 11MM
• 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 ; 3523771140
• MDR Report Key: 15501789
• Report Number: 1038671-2022-01187
• Device Sequence Number: 18104919
• 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: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/02/2026

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: 12/08/2016
• Device Model Number: 244-03-04
• 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: 09/08/2022
• Supplement Date Received by Manufacturer: 10/27/2023; 03/31/2026
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 11/08/2023; 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2008
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male