MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM LEFT SZ 3; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC FEMORAL PS CEM LEFT SZ 3
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	01/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 13 years post initial left tka, the 69 y/o female patient was having pain.Patient had a loose femur that was in flexion.Patient was revised to femur size 3 constrained, with posterior and distal augments, 2° coupler, 16 x 1 20 stem and a h 32 small cone femoral.A 3/15mm constrained liner.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images and x-rays attached.The devices are not available for evaluation due to they were held by hospital.
Additional Manufacturer Narrative
Section d10: concomitant products - logic tibia ps mod insrt sz 3 9mm (cat# 02-012-35-3009 / serial# (b)(6)) - lgc tibial fit tray cem sz 3f / 2t (cat# 02-012-45-3020 / serial# (b)(6)) - three peg patella 35mm (cat# 200-02-35 / serial# (b)(6)) - fluted stem extension 25l x 14 mm (cat# 204-34-02 / serial# (b)(6)) - tibial stem ext.Screw (cat# 204-70-00 / serial# (b)(6)) additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
The revision reported was most likely the result of a combination of prosthesis wear and aseptic loosening between the femoral component and the bone.The loosening may have led to an increase in cement and bone particles in the joint space and resulted in prosthesis wear or prosthesis wear from cement/bone overhang or instability may have contributed to particle-induced osteolysis and subsequent loosening.However, the contributions of loosening and prosthesis wear to the sequence of events cannot be determined as the devices were not available for evaluation and potential contributions from patient or user-related issues cannot be determined as initial post-operative radiographs and additional clinical information was not provided.

• Brand Name: LOGIC FEMORAL PS CEM LEFT SZ 3
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; gainesville 32653
• MDR Report Key: 18739669
• Report Number: 1038671-2024-00268
• Device Sequence Number: 15186906
• Product Code: JWH
• UDI-Device Identifier: 10885862001146
• UDI-Public: 10885862001146
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2025

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: 02/28/2016
• Device Model Number: LOGIC FEMORAL PS CEM LEFT SZ 3
• Device Catalogue Number: 02-010-01-0230
• 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: 01/26/2024
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2011
• 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
• Patient Age: 69 YR
• Patient Sex: Female