MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	244-24-15
Medical Device Problem Codes	Naturally Worn (2988); Lack of Effect (4065)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Osteolysis (2377); Skin Inflammation/ Irritation (4545); Radiolucent Lines (4848); Joint effusion (4849)
Date of Event	11/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the implant failed clinically, resulting in major bone osteolysis and necessitating revision surgery.Everything was fine until about 1.5 years ago when pain, effusion and decreased mobility began.X-ray showing osteolysis of the posterior condyles; comparing this x-ray with the one from 2019, degeneration is evident.Radiolucent lines are seen surrounding both components, which should be evaluated clinically (possible loosening?).Bone biopsies and microbiological and histological studies rule out infection.Infectious complication; fall; pressure ulcer; surgical wound inflammation; reintervention.Removal of ptj dta with findings of extensive synovitis and massive tibial and femoral osteolysis and revision arthroplasty with cemented tibia and femoral sleeve.There was no reported breakage of a device or surgical delay/prolongation.The patient required prolonged hospitalization as a direct result of this issue.The patient suffered permanent disability as direct result of this event.
Additional Manufacturer Narrative
D10: c040140g - orthocem g1 standard viscosity cement.204-63-05 - tibial augment block 1/2-sz 3 5mm.200-02-35 - three peg patella 35mm.204-63-05 - tibial augment block 1/2-sz 3 5mm.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
The explanted polyethylene insert demonstrated macroscopic wear at the time of revision.Regarding the intra-operative findings during the revision procedure, no evidence of femoral or tibial component loosening was observed.In addition, there were no findings suggestive of infection at the time of surgery.Microbiological and histological samples were obtained and, based on the available results, no evidence of infection has been identified.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b5, d9, h3, h6, h11.The following sections were corrected: h6.The complaint device was evaluated, and the reported event was confirmed.The review identified that the lateral radiographic views obtained one year prior to the revision and immediately prior to revision were provided.No significant interval changes are observed between the lateral views over the one year period.There appears to be separation between the anterior flange of the femoral component and the anterior cortex of the femur.There are areas that appear to be radiolucent regions superior to the femoral component.In addition, there appears to be an osteolytic cyst within the proximal tibia surrounding the tibial component.While these observations may be associated with component loosening, it was reported that no evidence of femoral or tibial component loosening was observed at the time of revision.There appears to be a posterior osteophyte extending from the proximal tibia.Furthermore, there appears to be calcifications of the superior and inferior aspects of the patella.The presence of these osteophytes and patellar calcifications may have contribut5ed to the reported reduction in range of motion; however, this cannot be definitively confirmed from the information provided.There does not appear to be a significant difference in the ap views over a one year period.However, there does appear to be radiolucencies along the medial aspect of the tibia, consistent with osteolysis.Comparison of the skyline radiographs obtained one year prior and immediately prior to revision appears to demonstrate a change in patellar alignment over the one yea period, suggesting a shift in patellar tracking.It was reported that the patient may have experienced quadriceps tendinopathy and a lateral tilt of both patellae.The quadriceps tendon, located superior to the knee, connects the quadriceps musculature to the superior aspect of the patella.Impairment of quadriceps function can result in imbalanced forces acting on the patella, which may contribute to altered patellar tracking within the femoral groove.However, this relationship cannot be definitively confirmed based on the information provided.The explanted tibial insert appears to have undergone fatigue wear with subsurface propagation of shear cracking prior to the eventual surface layer delamination and pitting of the articular surfaces.Fatigue wear, and particularly delamination, occurs secondary to cyclic shear stress between the tibial and femoral components and accelerated fatigue wear may be associated with oxidative degradation of the polyethylene.The v-shaped grooves may indicate that wear on the articular surface of the tibial insert was initiated by contact between incongruent surfaces of the tibial insert and ridge of the trochlear groove on the femoral component.There also appears to be wear along the anterior spine, and along the posterior spine.Anterior spine wear has been reported to occur under conditions involving elevated shear forces and rapid engagement of the femoral cam with the tibial spine during hyperextension.Posterior spine wear has been reported to occur under conditions involving increased shear forces and rapid engagement of the femoral cam with the tibial insert during knee flexion.However, the series of events cannot be confirmed from the information provided.There appears to be cracking along the sides of the returned tibial insert.In addition, there appears to be cold flow around the edges of the tibial insert.This pattern appears consistent with contact between the polyethylene and edge of the tibial tray.Furthermore, the medial foot of the tibial insert appears slightly smaller than the lateral foot.The observed cracking, cold flow, and plastic deformation are consistent with oxidative degradation of the polyethylene and may suggest elevated in vivo loading; however, this cannot be confirmed based on the available information.There appear to be areas of plastic deformation that may be consistent with contact between the body of the polyethylene insert and the outer ridge of the tibial tray.Circular witness marks also appear to be present along the backside of the tibial insert, which may be consistent with the polyethylene being pressed into the tibial tray screw holes.There appears to be cold flow of the polyethylene around the edge of the tibial tray during implantation.The presence of cold flow, plastic deformation, and witness marks around the tibial tray may indicate that the insert was subjected to elevated in vivo pressures; however, this cannot be confirmed based on the information provided.The locking feature on the backside of the insert appears to have deformation.It remains unclear whether this deformation occurred during removal of the device or whether it occurred during in-vivo loading.Furthermore, there appears to be damage to the polyethylene along the backside of the medial aspect of the tibial insert, as indicated by the red dashed region.This damage may be consistent with tool-related marks incurred during device removal; however, this cannot be definitively confirmed from the information provided.Operative notes and/or medical records were not provided for review of usage/ technique.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, may have resulted from reduced range of motion and prosthesis wear of their polyethylene insert.A contributing factor to the extent of wear on the tibial insert may have been the result of being packaged in a non-conforming bag for over five years.While the reported reduced range of motion cannot be confirmed, it may be related to the presence of a proximal tibial osteophyte and patellar calcifications.However, reduced range of motion and the series of events cannot be confirmed and potential contributions of user or patient-related consideration to the event could not be assessed as initial post-operative 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 4 15MM
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 23827385
• Report Number: 1038671-2025-03571
• Device Sequence Number: 14725872
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/26/2018
• Device Catalogue Number: 244-24-15
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2010
• 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 H11; SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 198 LB