MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	PS TIBIAL INSERTS SZ 4, 9MM
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	12/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately ten years post initial right tka, the 70 y/o male patient had a revision due to loose patella, poly issues and osteolysis of the tibia.Surgeon changed the liner, patella and tibial tray and also used an extension stem.There were no parts or pieces fell into the patient wound site.Patient was last known to be in stable condition following the event.X-rays and photos received.The devices are not available for evaluation as they were discarded by the hospital.No other patient information/medical history reported.
Additional Manufacturer Narrative
Section d10: concomitant products: - three peg patella 32mm (cat# 200-02-32 / serial# (b)(6)), - trapezoid tibial tray sz 4f/4t (cat# 204-04-44 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the revision reported was likely due to a combination of osteolysis and loosening between the patellar and tibial components and the underlying bone over the course of 11 years of implantation.Patellar maltracking may have been a contributing factor to the patellar wear and/or loosening.However, this cannot be confirmed as the devices were not available for evaluation and limited clinical information was provided.The most probable root cause associated with the reported event of ¿osteolysis¿ is associated with destruction or disappearance of bone tissue likely related to weakened integration of an implant at the bone-implant interface.Also, the most probable root cause associated with the event of ¿loosening¿ is associated with weakened integration of the device at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.Furthermore, the most probable root cause associated with the event of ¿prosthesis wear¿ is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely due to a combination of osteolysis and loosening between the patellar and tibial components and the underlying bone over the course of 11 years of implantation.Patellar maltracking may have been a contributing factor to the patellar wear and/or loosening.Unintended contact between the trochlear ridge of the femoral component during knee extension and/or third body wear may have been a contributing factor to the tibial insert damage.Patellar and tibial loosening cannot be confirmed as the devices were not available for evaluation and limited clinical information was 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 4, 9MM
• 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 ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17434080
• Report Number: 1038671-2023-01821
• Device Sequence Number: 6834702
• Product Code: JWH
• UDI-Device Identifier: 10885862048387
• UDI-Public: 10885862048387
• 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: 2012
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/04/2025

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: 03/06/2020
• Device Model Number: PS TIBIAL INSERTS SZ 4, 9MM
• Device Catalogue Number: 204-24-09
• 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: 07/13/2023
• Supplement Date Received by Manufacturer: 10/03/2023; 04/01/2025
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 10/31/2023; 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2012
• 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
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 100 KG