MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-24-09
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, on (b)(6) 2023 this patient was implanted with a 200-24-09 cr tibial insert sz4, 9mm, serial number (b)(6) on (b)(6) 2016.This patient is pending revision for wear of the polyethylene.No additional details are available at this time the insert was manufactured on 4/24/2015 and was packaged in a vacuum bag with no evoh.No other information was provided at this time.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.(d10) concomitant device(s): (b)(6), 02-012-45-4040 - bandeja tibial logic fit 4f/4t.(b)(6), 232-02-04 - comp.Femoral asimetrico poroso cr nº4 izq.
Additional Manufacturer Narrative
H3: 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.Possible causes 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 and radiographs were not provided.
Additional Manufacturer Narrative
The following sections have corrected information: h6.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.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.Possible causes 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 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: CR TIBIAL INSERT SZ4, 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 66 ct; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18346681
• Report Number: 1038671-2023-03009
• Device Sequence Number: 17695318
• Product Code: JWH
• UDI-Device Identifier: 10885862040299
• UDI-Public: 10885862040299
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/12/2025

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: 04/23/2023
• Device Catalogue Number: 200-24-09
• 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: 03/27/2024; 11/04/2024; 05/12/2025
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 03/29/2024; 12/02/2024; 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Patient Sex: Unknown