MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 2, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	204-22-09
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately eighteen years post initial right tsa, a patient was revised due to poly flaking and delamination, patella mal tracking that required a new patella and trimming/clean up of the effected bone.Patient was revised to exactech devices and patella and liner were exchanged.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-02986.The revision reported in (b)(4) was likely the result of patella wear and tibial insert deformation.The reported patella mal-tracking could not be confirmed.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.Potential contributions of manufacturing or user-related considerations to the event could not be assessed as the devices were not available for evaluation and radiographs, relevant clinical information, or complete product information 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: PS TIBIAL INSERTS SZ 2, 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 22285148
• Report Number: 1038671-2025-02313
• Device Sequence Number: 18375250
• Product Code: JWH
• UDI-Device Identifier: 10885862048226
• UDI-Public: 10885862048226
• 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: 2005
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2025

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 Catalogue Number: 204-22-09
• 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: 11/28/2023
• Initial Report FDA Received Date: 06/18/2025
• 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: PS CEM. FEMORAL SIZE 2, RIGHT (CAT# 234-03-02)CE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 80 KG