MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	CC TIBIAL INSERT SZ 2, 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.D10: concomittants: 204-04-23 - bandeja tib quilla trap cementada 1f/3t, 2f/3t (b)(6); 204-36-08 - vastago ext.16x80mm (b)(6); 204-36-08 - vastago ext.16x80mm (b)(6); 208-01-02 - femur cc nº2 (b)(6); 208-09-07 - adaptador femoral vastago cc 7 grados (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
During the week of april 17-25, representatives of exactech, inc.And exactech spain conducted an inperson site visit with (b)(6) hospital.As a result of that site visit and at exactech's request, the hospital provided a retrospective excel listing of revision related to polyethylene wear that have been performed since 2010.These cases have not previously been reported to exactech as complaints.This patient (b)(6)) was implanted with a 208-22-09-inserto tibial cc 2,9mm, serial number (b)(6) on (b)(6) 2014.The insert was manufactured on 7/29/2013 and was packaged in a vacuum bag with no evoh.The insert was manufactured on 7/29/2013 and was 0.62 years shelf age at the time of implant.Pending revision for wear of the polyethylene.No additional details are available at this time.
Additional Manufacturer Narrative
H6: the prosthesis wear reported may have been due to third body wear, patient-related conditions, instability, malalignment between the femoral and tibial components.However, this cannot be confirmed as the devices were not available for evaluation and radiographs were not provided.
Event or Problem Description
It was reported that the patient underwent an initial total knee arthroplasty.Subsequently, it was reported that the patient experienced prosthesis wear.As a result, the patient was scheduled for a revision on a future date.No further patient impact reported.No further information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b3, b5, d2b, g1, h6 - health effect - impact code, investigation findings, investigation conclusions, h7 and h11.B3: unknown date.The prosthesis wear reported may have been due to third body wear, patient-related conditions, instability, and/or malalignment between the femoral and tibial components, which led to prosthesis wear.However, this cannot be confirmed as the device was not available for evaluation and images of the explanted device/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
• 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 court; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17000018
• Report Number: 1038671-2023-01134
• Device Sequence Number: 16754476
• Product Code: JWH
• UDI-Device Identifier: 10885862054166
• UDI-Public: 10885862054166
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2026

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: 07/23/2018
• Device Model Number: CC TIBIAL INSERT SZ 2, 9MM
• Device Catalogue Number: 208-22-09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Supplement Date Received by Manufacturer: 06/30/2023; 03/18/2026
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 07/17/2023; 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2013
• 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; Other
• Patient Sex: Unknown