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); Inflammation (1932); Pain (1994); Implant Pain (4561)
Date of Event	09/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: pending investigation, h7: z-0019-2022.
Event or Problem Description
As reported, the patient had an initial left tka on (b)(6) 2014.In 2018, asymmetry was observed in the poly and there was pain and inflammation in the knee.In 2020 the patient continued to have pain and inflammation in the knee.The patient was revised on (b)(6) 2021.No patient information provided.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of prosthesis wear of the tibial insert possibly due to malalignment between the implants, high contact stresses during knee flexion/extension, third body wear, patient-related conditions, instability, or any combination of these possibilities.The cause of the prosthesis wear cannot be determined because minimal information was provided, the revised components were not returned for evaluation, and no radiographs were provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely the result of prosthesis wear of the tibial insert possibly due to malalignment between the implants, high contact stresses during knee flexion/extension, third body wear, patient-related conditions, instability, or any combination of these possibilities.The cause of the prosthesis wear cannot be determined because minimal information was provided, the revised components were not returned for evaluation, and no radiographs were 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18027232
• Report Number: 1038671-2023-02625
• Device Sequence Number: 14941010
• 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: 2014
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/23/2025

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: 08/30/2018
• Device Catalogue Number: 200-24-09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2023
• Supplement Date Received by Manufacturer: 01/09/2024; 04/22/2025; 04/18/2025
• Initial Report FDA Received Date: 10/29/2023
• Supplement Report FDA Received Date: 01/18/2024; 04/22/2025; 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2010
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown