MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CC FEMORAL SIZE 2, LEFT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-06-0220
Medical Device Problem Codes	Fitting Problem (2183); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	01/01/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via clinical study, that the 65 yo female patient experienced aseptic femoral loosening with persistent thigh pain related to micromotion of femoral stem with incomplete fixation.The date of adverse event onset is unk-unk-2016.Initially tried strengthening exercises as patient treatment.The patient was revised on (b)(6) 2021 along with medication.The patient¿s outcome was last known as resolved on (b)(6) 2021.
Additional Manufacturer Narrative
Concomitant medical products: 02-010-06-0220 - 4114527 - logic cc femoral size 2, left.02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t.02-012-60-1680 - logic stem ext 16mm x 80mm.208-05-02 - cc distal fem augment sz 2, 5mm.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of femoral loosening.The reported femoral loosening could not be confirmed.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, radiographs, and relevant clinical information 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: LOGIC CC FEMORAL SIZE 2, LEFT
• 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 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16844502
• Report Number: 1038671-2023-00514
• Device Sequence Number: 6870466
• Product Code: JWH
• UDI-Device Identifier: 10885862265654
• UDI-Public: 10885862265654
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2025

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
• Device Expiration Date: 09/12/2020
• Device Catalogue Number: 02-010-06-0220
• 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: 02/27/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2015
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Race: White