MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; SEE H10

Model Number OPTETRAK HI-FLEX TIBIAL INSERT SZ 3 9MM

Device Problems Peeled/Delaminated (1454); Naturally Worn (2988)

Patient Problems Pain (1994); Osteolysis (2377)

Event Date 09/15/2023

Event Type  Injury  

Event 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.

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.

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.

• Brand Name: OPTETRAK
• Type of Device: 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
• MDR Text Key: 336347093
• Report Number: 1038671-2024-00329
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862063991
• UDI-Public: 10885862063991
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K033883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/30/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2020
• Device Model Number: OPTETRAK HI-FLEX TIBIAL INSERT SZ 3 9MM
• Device Catalogue Number: 244-23-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0019-2022
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 66 KG