MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 2, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-49-2009
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	11/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this 75 y/o female returned surgeons office with complaints of pain, swelling, instability, and dissatisfaction with their right tka approximately 6 years post op.The patient had a recalled poly implant.Upon examination, the patient was scheduled to have a revision tka possible poly swap vs full revision.The patient had revision surgery on (b)(6) 2023.The patient underwent a poly insert swap and patella implant swap.Patient was last known to be in stable condition following the event.Unable to obtain x-rays.Product not returning - the implant(s) were sent to the lab and legal at the hospital.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation (d10) concomitant device(s): (b)(6): 02-010-03-0320 - logic cr femoral cem, right, sz 2.(b)(6): 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t.(b)(6): 200-02-26 - three peg patella 26mm.
Additional Manufacturer Narrative
The revision reported was likely the result of patellar and tibial insert prosthesis wear.The patellar and tibial insert wear was confirmed from the provided images.Additionally, the sequence of events as related to the reported wear and instability cannot be confirmed and the contributions of each to the reported event cannot be determined.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and 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 CR TIB INSERT SLOPE++, SZ 2, 9MM
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18301131
• Report Number: 1038671-2023-02958
• Device Sequence Number: 17047290
• Product Code: JWH
• UDI-Device Identifier: 10885862174314
• UDI-Public: 10885862174314
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

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: 06/17/2019
• Device Catalogue Number: 02-012-49-2009
• 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: 11/21/2023
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2011
• 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
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 71 KG