MAUDE Adverse Event Report: EXACTECH, INC. THREE PEG PATELLA 32MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-02-32
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Synovitis (2094); Osteolysis (2377); Joint Laxity (4526); Implant Pain (4561); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	01/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant products: (b)(6) - 02-010-03-0235 - logic cr femoral cem, left, sz 3.5, (b)(6) - 02-012-45-3535 - lgc tibial fit tray cem sz 3.5f / 3.5t, (b)(6)- 02-012-51-3513 - logic tib insert impl crc, sz 3.5, 13mm.The reason for the revision reported was likely due to the reported instability and prosthesis wear, or inclusion of the tibial insert in the packaging recall.Possible causes for polyethylene damage include malalignment between implants, high contact stresses during knee flexion, third body wear, patient-related conditions, inclusion of the polyethylene in the packaging recall, or any combination of these possibilities.Prosthesis wear of the patella implant could not be confirmed from the provided information.Instability may be the result of increased soft-tissue laxity (looseness), inadequate flexion of the implants, or improper positioning or alignment of the prosthesis.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, approximately 5.5 years post initial left tka, the male patient had an original exactech tka done.The patient returned to surgeon's office with complaints of pain, swelling, instability, and dissatisfaction with their tka.Upon examination, the patient was scheduled to have a revision tka possible poly swap vs full revision.The patient underwent a poly insert and patella implant swap.Patient was revised.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images and x-rays received.The devices are not available for evaluation due to the implant(s) is sent to the lab and legal at the hospital.Images, x-rays, ebi attached.No further medical/patient information provided.

• Brand Name: THREE PEG PATELLA 32MM
• 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: 22991716
• Report Number: 1038671-2025-02882
• Device Sequence Number: 8997073
• Product Code: JWH
• UDI-Device Identifier: 10885862039590
• UDI-Public: 10885862039590
• 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: 2018
• Device Explanted Year: 2024
• 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): 09/08/2025

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: 07/22/2023
• Device Catalogue Number: 200-02-32
• 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: 02/27/2024
• Initial Report FDA Received Date: 09/08/2025
• Date Device Manufactured: 07/24/2018
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 77 KG