MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM LEFT SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-01-0250
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	09/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
1038671-2024-01084 the reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, and femoral loosening or due to inclusion of the polyethylene in the packaging recall.However, the reported instability and femoral loosening could not be confirmed and potential contributions of manufacturing, user, or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.Concomitant devices: (b)(6) 02-010-01-0250 - logic femoral ps cem left sz 5 (b)(6) - 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t (b)(6) - 200-02-38 - three peg patella 38mm.
Event or Problem Description
It was reported via legal documentation that approximately 92 months after a left total knee replacement procedure, the patient underwent a revision procedure to address polyethylene wear, pain, swelling, and instability.No further issues or complications were reported.No additional information is available.

• Brand Name: LOGIC FEMORAL PS CEM LEFT SZ 5
• 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): E; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20301603
• Report Number: 1038671-2024-03698
• Device Sequence Number: 12957609
• Product Code: JWH
• UDI-Device Identifier: 10885862001177
• UDI-Public: 10885862001177
• Combination Product (Y/N): N
• PMA/510(K) Number: K033883
• 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: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2024

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: 02-010-01-0250
• 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: 09/24/2024
• Initial Report FDA Received Date: 09/25/2024
• Date Device Manufactured: 06/26/2015
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male