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	Appropriate Device Problem Term/Code Not Available (3191); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via clinical study, that the 53 yo female patient had an incomplete femoral fixation.Near complete 1mm radiolucency around femoral component and stem.No subsidence but evidence of lateral cortical hypertrophy and movement of femoral stem.Revision was recommended.The date of adverse event onset is unk-unk-unk.The patient¿s outcome was last known as continuing.
Additional Manufacturer Narrative
Concomitant medical products.Pma/510k:k150890.Concomitants: 02-012-35-2013 logic tibia ps mod insrt sz 2 13mm, 02-012-45-2020 lgc tibial fit tray cem sz 2f / 2t, 204-34-04 fluted stem extension 40l x 14 mm, 02-012-60-1412 logic stem ext 14mm x 120mm, 02-010-06-0521 logic post.Aug.Block size 2, 5mm, 208-06-02 cc distal fem augment sz 2, 10mm.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The most likely reason for the reported event is an insufficient bond between the femoral component and the bone, which led to aseptic (non-infected) femoral loosening.Potential contributions of user-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.

• 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: 16616956
• Report Number: 1038671-2023-00511
• Device Sequence Number: 17679494
• 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: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2025

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: 11/08/2020
• 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: 01/17/2025
• Initial Report FDA Received Date: 03/26/2023
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2015
• 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: Required Intervention; Other
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 84 KG