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

Catalog Number	02-010-06-0240
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: 06001016009, a10012 - gps implant kit v2; serial #: (b)(4), category #: 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t; serial #: (b)(4), category #: 208-06-04 - cc distal fem augment sz 4, 10mm; serial #: (b)(4), category #: 02-012-60-2080 - logic stem ext 20mm x 80mm; serial #: (b)(4), category #: 02-010-06-0541 - logic post.Aug.Block size 4, 5mm; serial #: (b)(4), category #: 02-010-06-0541 - logic post.Aug.Block size 4, 5mm; serial #: (b)(4), category #: 204-70-00 - tibial stem ext.Screw; serial #: (b)(4), category #: 208-06-04 - cc distal fem augment sz 4, 10mm; serial #: (b)(4), category #: 02-012-61-2000 - logic offset stem ext coupler 2mm; serial #: (b)(4), category #: 02-012-60-1440 - logic stem ext 14mm x 40mm; serial #: (b)(4), category #: 02-012-66-2000 - metaphyseal tibial cone, ml32mm; serial #: (b)(4), category #: 02-012-44-4015 - logic tibia implant psc insert, sz 4, 15mm serial number (b)(4) is confirmed to have been packaged in a vacuum bag that does not contain evoh.
Event or Problem Description
It was reported via clinical study, that the 62 yo male patient experienced aseptic femoral loosening resulting in swelling and pain.The patient reported that the left knee started feeling looser.The mri confirmed movement.The date of adverse event onset is unk-unk-2021.The patient was treated with physical therapy.The patient¿s outcome was last known as continuing.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1/d2a/d2b, h6.Mdr section codes updated/corrected: b, c, d, e, f, g.The reason for the reported event cannot be confirmed from the information provided but may have been due to femoral loosening.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 4, 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: 16600555
• Report Number: 1038671-2023-00494
• Device Sequence Number: 17921827
• Product Code: JWH
• UDI-Device Identifier: 10885862265678
• UDI-Public: 10885862265678
• 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: 2017
• 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): 04/16/2025

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: 08/07/2021
• Device Catalogue Number: 02-010-06-0240
• 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: 02/27/2023
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 04/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2016
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 100 KG