MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	244-24-09
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Lack of Effect (4065)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Synovitis (2094); Fibrosis (3167); Joint Laxity (4526); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849)
Date of Event	06/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 214 months after a left total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear.Revision surgery operative notes were provided.Patient left the operating room in stable condition.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability and loss of range of motion or due to inclusion of the polyethylene in the packaging recall.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.H6: corrected health effect, medical device and investigation clinical codes.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b5.The following sections were corrected: h6.
Event or Problem Description
Additional information received via operative report stated the pre-op diagnosis was fibrosis of the left knee joint.There was significant effusion and synovitis.No purulence.Fluid and tissue cultures were sent.There was no evidence of prosthesis loosening.The polyethylene was removed.The femoral component was removed without any significant bone loss.The tibial component was removed without significant bone loss.The patella was carefully inspected.It was well fixed with no wear.Removal of the button would not have allowed for placement of another patellar button, therefore, it was left in place.There was a metaphyseal void in the tibial canal that required a cone and this was prepared in the standard fashion.Augments were placed in the femur in order to ensure good prosthetic bone contact and proper rotation and joint line restoration.Surfaces were copiously irrigated.Using antibiotic impregnated cement, the tibial components were press-fit into place, followed by the femoral components.The real insert was placed.The knee joint was irrigated.The patient was closed and transferred to the recovery room in stable condition.The patient tolerated the procedure well.Procedure findings noted stiffness and flexion extension mismatch.Additional information received from the facility indicated that the patient was revised due to femoral knee debonding/loosening and fibrosis of the left knee joint.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h11 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.In august of 2021, it was discovered that a bag used in the packaging of our polyethylene inserts had been produced outside of our quality specifications.The use of these non-conforming bags may enable increased oxygen diffusion to the uhmwpe (ultra-high molecular weight polyethylene) insert, resulting in increased oxidation of the material relative to inserts packaged with bags that conform to specifications.For inserts with greater than five years of shelf life, increased oxidation of the inserts can lead to premature polyethylene wear resulting in revision surgery.However, while it was packaged in a non-conforming vacuum bag, this tibial insert was on the shelf for less than 5 years before it was implanted.Additionally, these devices appear to have been implanted over ten years prior to the reported event.Based on the age of the patient¿s devices and the available information, there is no evidence or information to suggest that the reported loosening is manufacturing-related.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 prosthesis wear, instability, loss of range of motion, and femoral loosening or due to inclusion of the polyethylene in the packaging recall.Additionally, these devices appear to have been implanted over ten years prior to the reported event.Potential contributions of users and patient-related considerations to the event could not be assessed as the devices were not available 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.

• Brand Name: OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 9MM
• 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 court; gainesville 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville 32653 ; 3523771140
• MDR Report Key: 19711737
• Report Number: 1038671-2024-02342
• Device Sequence Number: 8920378
• Product Code: JWH
• UDI-Device Identifier: 10885862064035
• UDI-Public: 10885862064035
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/24/2026

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: 06/25/2011
• Device Catalogue Number: 244-24-09
• 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: 07/09/2024
• Supplement Date Received by Manufacturer: 04/01/2025; 11/03/2025; 04/17/2026
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 04/01/2025; 11/14/2025; 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2006
• 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