MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 3, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	204-23-13
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	11/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this 78 y/o female patient's right knee was revised 10 years post op.Surgeon performed a poly exchange ¿ patella loose and worn.The patient was revised due to poly wear and patella loosening, the patient was revised to a 35mm patella and a sz 3 13mm tibial insert.Fragments of polyetherleyne that were present in the knee joint were removed.This took about 5-15 minutes causing no adverse event as a result.Patient was last known to be in stable condition following the event.Product not returning, it was discarded.
Additional Manufacturer Narrative
(h3) pending evaluation.(d10) concomitant device(s): three peg patella, 29mm - 200-02-29 - 2717460.Cemented trapezoid tray -3f/3t - 204-04-33 - 2686168.Ps cem.Femoral size 3, right - 234-03-03 - 2763905.
Additional Manufacturer Narrative
The revision reported was likely the result of prosthesis wear and patella loosening.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.The extent and root cause of the prosthesis wear and patella loosening could not be determined as the devices were not returned for evaluation.
Additional Manufacturer Narrative
D10: cemented trapezoid tray -3f/3t - 204-04-33 - (b)(6).Ps cem.Femoral size 3, right - 234-03-03 - (b)(6).The revision reported was likely the result of prosthesis wear of the patella and patella loosening.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.The extent and root cause of the prosthesis wear and patella loosening could not be determined as the devices were not returned for evaluation.Additionally, neither the patellar loosening nor the insert wear could be confirmed and these devices appear to have been implanted for over ten years prior to the reported event.This follow-up report is being submitted to relay corrected information.The following sections were corrected: d10, h11 updated investigation, h6 clinical code, investigation findings, and investigation conclusions.This follow-up report is being submitted to relay additional information.The following sections were updated: h6 component code.

• Brand Name: PS TIBIAL INSERTS SZ 3, 13MM
• 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: 18422021
• Report Number: 1038671-2023-03082
• Device Sequence Number: 7867212
• Product Code: JWH
• UDI-Device Identifier: 10885862048325
• UDI-Public: 10885862048325
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/13/2025

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: 08/03/2020
• Device Catalogue Number: 204-23-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 03/15/2024; 05/09/2025
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 03/29/2024; 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2012
• 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
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 80 KG