MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CC FEMORAL SIZE 3, RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	N/A
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Osteolysis (2377); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/16/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation the patient had a right knee replacement on (b)(6)2015.Approximately 2 years and 4 months after the initial procedure the patient had a right knee revision on (b)(6) 2018.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 02-010-06-0330 - tru cc femoral size 3 right; (b)(6), 02-010-06-0532 - tru post.Aug.Size 3, 10mm; (b)(6), 02-012-45-3020 - lgc tibial fit tray cem sz 3f / 2t; (b)(6), 02-012-60-1280 - tru stem ext 12mm x 80mm; (b)(6), 02-012-60-1680 - tru stem ext 16mm x 80mm; (b)(6), 1400-ig - cemex genta high viscosity 40g kit; (b)(6), 208-06-03 - cc distal fem augment sz 3, 10mm; (b)(6), tpa-18 - cement restrictor small.Pending investigation.
Additional Manufacturer Narrative
As a result of additional information received.D10.Concomitants: 4146625 02-012-65-3015 - tru cc tib insert size 3, 15mm.4101341 02-010-06-0532 - tru post.Aug.Size 3, 10mm.4128216 02-012-45-3020 - lgc tibial fit tray cem sz 3f / 2t.4113010 02-012-60-1280 - tru stem ext 12mm x 80mm.4131732 02-012-60-1680 - tru stem ext 16mm x 80mm.Aa8010 1400-ig - cemex genta high viscosity 40g kit.4058509 208-06-03 - cc distal fem augment sz 3, 10mm.Aa8460 tpa-18 - cement restrictor small.
Event or Problem Description
As reported via legal documentation, a patient had a right knee revision on (b)(6) 2015.Approximately 2 years and 4 months after the revision the patient had a second right knee revision on (b)(6) 2018 revision op report found that both the femur and the tibia were grossly loose and extensive bone loss on both sides.The patella component was securely fixed and was not revised.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: a3 h6 h8.The following sections were corrected: b1 b2 d1 d4: model number, catalog number, serial number and udi h4 h6.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, disassembly, tibial loosening, and femoral loosening or due to inclusion of the polyethylene in the packaging recall.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.

• Brand Name: LOGIC CC FEMORAL SIZE 3, RIGHT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17670416
• Report Number: 1038671-2023-02133
• Device Sequence Number: 20609216
• Product Code: JWH
• UDI-Device Identifier: 10885862265715
• UDI-Public: 10885862265715
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/17/2025

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: 09/12/2020
• Device Model Number: N/A
• Device Catalogue Number: 02-010-06-0330
• 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: 07/19/2023
• Supplement Date Received by Manufacturer: 08/15/2023; 01/16/2025
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 10/25/2023; 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female