MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM LEFT SZ 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-01-0240
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Scar Tissue (2060); Joint Laxity (4526); Implant Pain (4561)
Date of Event	06/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3/g4, h6.The following sections were corrected: h6.Mdr section codes updated/corrected: a, b, c.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, femoral loosening, and instability, failure of the cement used to secure the femoral component to the femoral bone, which led to loosening at the cement-implant interface, or due to inclusion of the polyethylene in the packaging recall.However, this cannot be confirmed as there were no details regarding cementing technique or environmental conditions provided and the device was not returned for evaluation.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.
Additional Manufacturer Narrative
D10: concomitant devices: (b)(6), 02-012-41-4030 - logic tibia traptray cem sz 4f/3t, (b)(6), 02-012-35-4009 - logic tibia ps mod insrt sz 4 9mm, (b)(6), 02-010-01-0240 - logic femoral ps cem left sz 4, ((b)(6), 200-02-35 - three peg patella 35mm.Multiple mdr reports were filed for this event, please see associated report: 1038671-2023-00628.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported via legal documentation that approximately 116 months after a left total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, pain and instability.Initial surgery and revision surgery operative notes were provided.Post operative diagnosis noted left total knee failure aseptic.Intraoperatively it was noted that a complex scar revision was necessary.It was noted that the femur was debonding from the cement.Posterior osteophytes were removed.Intraoperative x-rays were taken and reviewed prior to completion of the operation, and it was noted that no fractures were seen, and all implants were in acceptable position.No medical or surgical interventions were reported.No additional information is available.

• Brand Name: LOGIC FEMORAL PS CEM LEFT SZ 4
• 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 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21101851
• Report Number: 1038671-2025-00146
• Device Sequence Number: 9161261
• Product Code: JWH
• UDI-Device Identifier: 10885862001160
• UDI-Public: 10885862001160
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 02/04/2025

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: 07/22/2017
• Device Catalogue Number: 02-010-01-0240
• 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: 02/23/2024
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 02/04/2025
• Date Device Manufactured: 07/23/2012
• 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: Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female