MAUDE Adverse Event Report: EXACTECH, INC. SPECIFIC DEVICE NOT REPORTED; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LOGIC FEMORAL PS CEM RIGHT SZ 2.5
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094); Osteolysis (2377); Implant Pain (4561); Insufficient Information (4580)
Date of Event	02/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
It was reported via legal documentation the patient had a right knee replacement on (b)(6) 2013.Approximately 7 years and 7 months after the initial procedure the patient had a right knee revision on (b)(6) 2021.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Unable to locate patient in ebi.Historical record and smartsolve searched for sn/patient name with no results.
Additional Manufacturer Narrative
The reason for the revision reported in (b)(4) cannot be confirmed from the information provided but may be the result of femoral loosening and 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.D4: corrected.G4: corrected.H6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: SPECIFIC DEVICE NOT REPORTED
• 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 ; gainesville 32653
• MDR Report Key: 18417562
• Report Number: 1038671-2023-03069
• Device Sequence Number: 6826671
• Product Code: JWH
• UDI-Device Identifier: 10885862001221
• UDI-Public: 10885862001221
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2025

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: 03/06/2018
• Device Model Number: LOGIC FEMORAL PS CEM RIGHT SZ 2.5
• Device Catalogue Number: 02-010-01-0325
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2023
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 01/22/2025
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown