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

Catalog Number	02-012-48-4009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Swelling/ Edema (4577)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitants: (b)(6), 200-02-35 three peg patella 35mm.(b)(6), 02-010-04-0340 logic cr femoral por, right, sz 4.(b)(6), 02-012-45-4040 lgc tibial fit tray cem sz 4f / 4t.These devices are used for treatment not diagnosis.There is no other information available.Pending investigation.
Event or Problem Description
It was reported via legal documents that a patient is having right knee pain and swelling.The 67-year-old male patient had an initial right tka on (b)(6) 2018.The patient was revised on (b)(6) 2024, approximately 5 years, 3 months after implant; the insert and patella were exchanged due to wear/pitting.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition.Photos were provided.Unable to obtain x-rays.Product not returning - disposed at the hospital.The patient was last known to be in stable condition.There is no other patient demographic or medical history available.No other information is available.
Additional Manufacturer Narrative
H11.Additional manufacturer narrative- additional information added/ b7.Bilateral knee replacements.H6.Health effect code.H3.Investigation results-the revised components were not returned to exactech for evaluation and no radiographs were provided.Images were provided.The revised tibial insert shows minimal signs of wear.There are no obvious signs of delamination or oxidative wear in the provided images.Minor pitting/scratching is on the lateral articular surface.The design of the optetrak family of devices has been in the field since 1997 (logic 2010).Exactech complaint history from 01/01/2008 ¿ 04/01/2024 was reviewed for revisions of tibial inserts due to prosthesis wear.(b)(4).This is considered ¿very low¿.Therefore, this does not appear to be design-related.A review of the risk management documents was conducted to ensure the risk was included and the occurrence is below the threshold.The revision reported was likely the result of presumed prosthesis wear.However, images of the revised components do not show signs of excessive prosthesis wear inconsistent with being implanted.

• Brand Name: LOGIC CR TIB INSERT SLOPE+
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon
• MDR Report Key: 19039607
• Report Number: 1038671-2024-00738
• Device Sequence Number: 17952571
• Product Code: JWH
• UDI-Device Identifier: 10885862174482
• UDI-Public: 10885862174482
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K11140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2024

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: 03/14/2026
• Device Catalogue Number: 02-012-48-4009
• 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: 03/18/2024
• Supplement Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2018
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 77 KG