MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK HI-FLEX TIBIAL INSERT SZ 3 9MM; SEE H10

Model Number	N/A
Medical Device Problem Codes	Peeled/Delaminated (1454); Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Implant Pain (4561)
Date of Event	09/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 66 yo female patient, initial right knee implanted on (b)(6) 2012, utilizing gps, underwent a revision procedure on (b)(6) 2023, approximately 11 years 4 months post the initial procedure 2017, lysis in the tibial implant was noted.In 2021 the patient experienced progressive pain in their right knee.The revision was performed in 2023.Delaminated polyethylene in the central pivot and broken patella poly was indicated.The patient was revised with a competitor¿s devices.No parts or pieces fell into patient wound site and there was no reported surgical delay/prolongation during the procedure.No x-rays were provided.The explanted devices are not available for return.The surgeon did not want to provide them.Device images were provided.No further information.
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.D10: concomitants: (b)(6), 200-02-32 - rotula tres tetones 32mm.(b)(6), 244-03-03 - comp.Femoral asimetrico cementado hf ps nº3 drch.(b)(6), 200-04-32 - bandeja tib cementada aleta 3f/2.T additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of joint instability and uneven force distribution across the joint, which led to wear of the tibial insert.Fracture of the patella was also reported but the cause, extent, and order of events cannot be determined from the information provided.The revised component(s) was not returned for evaluation and no radiographs were provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were updated: corrected - h6 clinical code changed from 1994 pain to e2109 implant pain, medical device problem code 1454 peeled/delaminated changed to a051207 unstable, investigation findings codes 4243 and 3252 no longer apply, investigation conclusion code changed from 22 known inherent risk of device to d1501 cause linked to device but unable to trace more specifically.
Event or Problem Description
It was reported that a patient, underwent a revision procedure approximately 11 years 4 months post the initial procedure.Approximately 5 years after the initial surgery, lysis in the tibial implant was noted.Approximately 9 years after initial surgery, the patient experienced progressive pain in their right knee.Approximately 2 years after the pain in their right knee, the revision was performed.Delaminated polyethylene in the central pivot and broken patella poly was indicated.The patient was revised with a competitor¿s devices.No parts or pieces fell into patient wound site and there was no reported surgical delay/prolongation during the procedure.No x-rays were provided.The explanted devices are not available for return.The surgeon did not want to provide them.Device images were provided.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-04903.The revision reported was likely the result of joint instability and uneven force distribution across the joint, which led to wear of the tibial insert.Fracture of the patella was also reported but the cause, extent, and order of events cannot be determined from the information provided.The revised component(s) was not returned for evaluation and no radiographs were 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 3 9MM
• Common Device Name: SEE H10
• 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: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18789599
• Report Number: 1038671-2024-00329
• Device Sequence Number: 15407344
• Product Code: JWH
• UDI-Device Identifier: 10885862063991
• UDI-Public: 10885862063991
• 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: 2012
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/25/2025

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: 01/26/2020
• Device Model Number: N/A
• Device Catalogue Number: 244-23-09
• 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: 01/29/2024
• Supplement Date Received by Manufacturer: 05/16/2024; 12/03/2024; 03/25/2025
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 05/30/2024; 12/13/2024; 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2012
• 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.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 66 KG