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

Catalog Number	200-03-32
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Distress (2329); Discomfort (2330); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitants: (b)(6), 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t; (b)(6), 204-30-08 - stem extension 80l x10 mm; (b)(6), 204-32-08 - stem extension 80l x12 mm; (b)(6), 208-09-05 - cc stem ext adaptor 5 degree.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-00905 and 1038671-2025-00397.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, femoral loosening, and patellar loosening.Or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs 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
Implant date: (b)(6) 2016.Explant date: (b)(6) 2021.The devices were implanted for approximately 4 years, 6 months.Patient experienced prosthesis wear, instability, femoral loosening, patellar loosening, discomfort, synovitis, pain and distress.Post operative diagnosis: mechanical loosening.Revision of all components to other non exactech components.Upon opening the knee joint, the femoral component was noted to be grossly loose and this was easily extracted by hand.Similarly, the patellar component was totally loose and easily pried off of the remaining patellar bone stock.Sterile dressings were applied and the patient was extubated in stable condition.

• Brand Name: ONE 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 21254250
• Report Number: 1038671-2025-00496
• Device Sequence Number: 9077156
• Product Code: JWH
• UDI-Device Identifier: 10885862039651
• UDI-Public: 10885862039651
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/28/2025

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: 09/01/2019
• Device Catalogue Number: 200-03-32
• 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: 04/11/2023
• Initial Report FDA Received Date: 01/28/2025
• Date Device Manufactured: 09/02/2014
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female