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	Naturally Worn (2988)
Health Effect - Clinical Codes	Synovitis (2094); Osteolysis (2377); Implant Pain (4561); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 118 months after a right total knee replacement procedure, the patient underwent a revision procedure to address polyethylene wear, pain, swelling, stiffness, osteolysis around the proximal tibia, synovitis, abnormal wear of the tibial insert on the medial side and oxidation of the lateral side, and delamination of the patella.Revision surgery operative notes were provided.Patient left the operating room in stable condition.Post operative diagnosis noted wear of the implant.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
D10: 02-012-47-3515 - logic cr tib insert std, sz 3.5, 15 mm, 02-012-47-3511 - logic cr tib insert std, sz 3.5, 11 mm, 02-012-45-3525 - lgc tibial fit tray cem sz 3.5f / 2.5t, 02-012-45-3525 - lgc tibial fit tray cem sz 3.5f / 2.5t, 02-010-03-0235 - logic cr femoral cem, left, sz 3.5, 02-010-03-0335 - logic cr femoral cem, right, sz 3.5.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-01247.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear 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.".

• 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21469159
• Report Number: 1038671-2025-01242
• Device Sequence Number: 3568188
• Product Code: JWH
• UDI-Device Identifier: 10885862039651
• UDI-Public: 10885862039651
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2023
• 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): 02/26/2025

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 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: 04/29/2024
• Initial Report FDA Received Date: 02/26/2025
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female