MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ3, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	CR TIBIAL INSERT SZ3, 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	02/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
During the week of april 17-25, representatives of exactech, inc.And exactech spain conducted an in-person 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.On 28-nov-2023, updates to the excel listing were provided.This 57 y/o male patient was implanted with a optetrak hi-flex tibial insert, sz 2, 9mm (cat#: 200-23-09 / serial#: (b)(6) on (b)(6) 2008.The insert was manufactured on 3-oct-2008 and was packaged in a vacuum bag with no evoh.The insert was 0.04 years of shelf age at the time of implant.Patient was revised on (b)(6) 2020 approximately 11.30 years post implant.No additional details are available at this time.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H3: the revision reported was most likely due to prosthesis wear over the course of 11 years of implantation secondary to patient-related issues.Possible contributing factors for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.However, this cannot be confirmed as the device was not available for evaluation and images of the explanted device /radiographs were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6 clinical code, investigation findings and investigation conclusions.

• Brand Name: CR TIBIAL INSERT SZ3, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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: kate jacobson
• MDR Report Key: 18332525
• Report Number: 1038671-2023-02985
• Device Sequence Number: 6703196
• Product Code: JWH
• UDI-Device Identifier: 10885862040244
• UDI-Public: 10885862040244
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K932776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/25/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/02/2016
• Device Model Number: CR TIBIAL INSERT SZ3, 9MM
• Device Catalogue Number: 200-23-09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 03/20/2024; 04/14/2025
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 06/11/2024; 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2008
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 85 KG