MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ3, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	CR TIBIAL INSERT SZ3, 13MM
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	04/26/2023
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 ubarmin 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 patient was implanted with a cr tibial insert sz 3, 13mm (cat# 200-23-13 / serial# (b)(6) on (b)(6) 2004.Patient was revised on (b)(6) 2023 approximately 18.50 years post implant.There was no bone defect in femur.Patient had a aori 2a medial plateau defect.Patient was revised to competitor¿s devices.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 likely the result of osteolysis and prosthesis wear after 18 years of implantation.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(s) were not available for evaluation and pre-revision radiographs were not provided.
Additional Manufacturer Narrative
Correction: h6.
Additional Manufacturer Narrative
Correction: h6.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were updated: h6 findings (wear problem removed), conclusions.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h3, h6.H3: the revision reported was likely the result of insert prosthesis wear over the course of 18 years.Possible causes for polyethylene wear observed may include high contact stresses during knee flexion, third body wear, patient-related conditions, instability or any combination of these possibilities.However, these possible causes cannot be confirmed as the devices were not available for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d4, h4.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 SZ3, 13MM
• 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: 18332489
• Report Number: 1038671-2023-02989
• Device Sequence Number: 6712402
• Product Code: JWH
• UDI-Device Identifier: 10885862040268
• UDI-Public: 10885862040268
• 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: 2004
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/12/2025

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: 10/09/2007
• Device Model Number: CR TIBIAL INSERT SZ3, 13MM
• Device Catalogue Number: 200-23-13
• 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; Not provided; 06/21/2024; 11/05/2024; 06/25/2025; 08/12/2025
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 06/11/2024; 06/24/2024; 06/26/2024; 12/03/2024; 07/15/2025; 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2002
• 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 Sex: Unknown