MAUDE Adverse Event Report: EXACTECH, INC. THREE PEG PATELLA 29MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-02-29
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	03/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant products: - three peg patella 29mm (cat# 200-02-29 / serial# (b)(6)).The revision reported was likely due to the reported instability, or due to the inclusion of the polyethylene tibial insert in the packaging recall.Prosthesis wear of the patella appears to be an incidental finding during revision and does not appear to be the cause for the revision.Additional reasons for the reported revision may be tibial insert prosthesis wear and instability, however, the reported instability and tibial insert prosthesis wear could not be confirmed from the provided information.Additionally, a contributing factor to the reported wear may have been the result of the tibial insert being packaged in a non-conforming vacuum bag for more than five years.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and radiographs and relevant clinical 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.
Event or Problem Description
As reported, the female patient had an original exactech left tka.The patient presented back to surgeon's office with complaints of pain, swelling, instability, and dissatisfaction with their left tka.The patient has a recalled implant.Upon examination, the patient was scheduled to have a revision tka possible poly swap vs full revision.The patient had revision surgery on (b)(6) 2023.The patient underwent a left tka tibial poly swap and patella implant swap and revised to a truliant crc insert size 1.5, 13mm and optetrak 3 peg patella cemented 29m.The patient left the operating room (or) stable.There was no breakage of a device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images received.The devices are not available for evaluation due the implant was required to be sent to the lab and legal at the hospital.

• Brand Name: THREE PEG PATELLA 29MM
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 22814268
• Report Number: 1038671-2025-02762
• Device Sequence Number: 9014345
• Product Code: JWH
• UDI-Device Identifier: 10885862039583
• UDI-Public: 10885862039583
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 08/15/2025

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: 10/04/2021
• Device Catalogue Number: 200-02-29
• 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: 03/31/2023
• Initial Report FDA Received Date: 08/15/2025
• Date Device Manufactured: 10/06/2016
• 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: Hospitalization; Required Intervention
• Patient Sex: Female