MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 4, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	PS TIBIAL INSERTS SZ 4, 13MM
Medical Device Problem Codes	Crack (1135); Detachment of Device or Device Component (2907); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Scar Tissue (2060); Synovitis (2094); Osteolysis (2377); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849)
Date of Event	09/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products: three peg patella, 35m (cat#: 200-02-35 / serial#: (b)(6).Cemented trapezoid tray 4f/5t (cat#: 204-04-45 / serial#: (b)(6).Ps cem.Femoral size 4, right (cat#: 234-03-04 / serial#: (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately ten years post initial right tka, the 69 y/o male patient had a revision due to massive osteolysis issue due to poly wear.All implants were removed.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Photos and x-rays received.The devices are not available for evaluation as they were discarded at the hospital.
Additional Manufacturer Narrative
The revision reported was likely due to prosthesis wear which may have been due to instability, orientation of the components, patient related conditions, third body wear, incomplete seating of the insert, or any combination of these possibilities.It also appears that the insert disassembled from the tibial tray.Based on the information provided, the sequence of event could not be determined.It is unclear if the disassociation of the insert led to prosthesis wear and/or if the prosthesis wear may have led to the disassociation of the insert.Additionally, the insert was packaged in a non-conforming vacuum bag for over five years, which may have contributed to the reported wear.Additional information: d9.
Additional Manufacturer Narrative
The revision reported was likely due to prosthesis wear of the insert and prosthesis wear and fracture of the patella.Prosthesis wear of the tibial insert may have been due to instability, orientation of the components, patient related conditions, third body wear, incomplete seating of the insert, or any combination of these possibilities.It also appears that the insert disassembled from the tibial tray.Based on the information provided, the sequence of events could not be determined.It is unclear if the disassociation of the insert led to prosthesis wear and/or if the prosthesis wear may have led to the disassociation of the insert.Additionally, the insert was packaged in a nonconforming vacuum bag for over five years, which may have contributed to the reported wear.D10: ps cem.Femoral size 4, right (cat# 234-03-04 / serial# (b)(6)).This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: d10, h6 component code the following sections were corrected: b2, h3, h6 clinical code, problem code, type of investigation, investigation findings, and investigation conclusions.

• Brand Name: PS TIBIAL INSERTS SZ 4, 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 ; 3523771140
• MDR Report Key: 17822513
• Report Number: 1038671-2023-02378
• Device Sequence Number: 2440365
• Product Code: JWH
• UDI-Device Identifier: 10885862048400
• UDI-Public: 10885862048400
• 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: 2014
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/22/2016
• Device Model Number: PS TIBIAL INSERTS SZ 4, 13MM
• Device Catalogue Number: 204-24-13
• 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: 09/07/2023
• Supplement Date Received by Manufacturer: 01/04/2024; 04/15/2025
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 04/18/2024; 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2008
• 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 H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 80 KG