MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	SIZE 3.5 RIGHT FEMUR
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Scar Tissue (2060); Osteolysis (2377)
Date of Event	04/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product: 5 insert 13mm psc.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately six years post initial right tka, the female patient had a revision of femur and poly with stem/augments.Patient was revised to an exactech cc femur, stem augments and cc insert.There was no breakage of the device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain photo/x-rays.The devices are not available for evaluation due to patient's lawyer requested implants.No additional information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: d1, d4, d10, g4, h6.D10: concomitant devices: (b)(6) 204-70-00 - tibial stem ext.Screw; (b)(6) 02-012-45-3535 - lgc tibial fit tray cem sz 3.5f / 3.5t; (b)(6) 02-010-01-0335 - logic femoral ps cem right sz 3.5; (b)(6) 204-34-02 - fluted stem extension 25l x 14 mm; (b)(6) 200-02-32 - three peg patella 32mm.
Additional Manufacturer Narrative
The revision reported was likely the result of prosthesis wear and failure of the cement used to secure the femoral component to the femoral bone, which led to loosening at the cement-implant interface; however, this cannot be confirmed.Additionally, a contributing factor to the prosthesis wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.However, this could not be confirmed as the devices were not returned 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 TIBIA IMPLANT PSC INSERT, SZ 3.5, 13MM
• 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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16833877
• Report Number: 1038671-2023-00861
• Device Sequence Number: 16985590
• Product Code: JWH
• UDI-Device Identifier: 10885862173614
• UDI-Public: 10885862173614
• 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: 2017
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/19/2025

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: 09/13/2019
• Device Model Number: SIZE 3.5 RIGHT FEMUR
• Device Catalogue Number: 02-012-44-3513
• 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: 04/07/2023
• Supplement Date Received by Manufacturer: 12/27/2024; 02/18/2025
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 01/14/2025; 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2011
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female