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

Catalog Number	02-012-48-2009
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Swelling/ Edema (4577)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: pending device return and investigation.
Event or Problem Description
As reported, the patient had an initial right tka in 2018.The patient presented 5 years later complaining of knee swelling and pain.The surgeon diagnosed wear of the tibial insert and revision surgery was performed on an unknown date.Breakage and wear was observed in the retrieved tibial insert.No metallosis was found.The surgeon decided there was no problem with the locking mechanism of the tibial tray.All proliferative tissue was removed and the insert was replaced.There was no reported surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of joint instability, which allowed for wear across the entire superior surface of the tibial insert.Oxidative degradation appears to have been a contributing factor to the wear, delamination, and full-thickness fracture of the tibial insert.The tibial insert may have been packaged in a non-conforming vacuum bag for more than five years before being implanted, which could have contributed to embrittlement of the polyethylene.However, this cannot be confirmed because the serial number was not provided and therefore, the manufacturing data cannot be reviewed.Section h11: *the following sections have corrected information: (h6) component code: 734, bearings.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6 clinical code, problem code, and investigation conclusions.

• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18008371
• Report Number: 1038671-2023-02606
• Device Sequence Number: 7276681
• Product Code: JWH
• UDI-Device Identifier: 10885862174284
• UDI-Public: 10885862174284
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 05/13/2025

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 Catalogue Number: 02-012-48-2009
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 04/23/2024; 04/28/2025
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 04/30/2024; 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Female
• Patient Weight: 52 KG