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

Model Number	02-012-49-2009
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	06/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: 2141597 - 02-010-03-0200 - logic cr cement femoral left, 0 4716377 - 02-012-45-0000 - logic fit cement tivial tray 0f/0t 6000017114 - a10012 - gps disposable kit 842660 - tn190-119-05 - oscillating blade m-class 19x1.19x105 812591 - tn193-119-90 - oscillator blade m-class 19/13x 1.19x90mm unassigned - z99007 - logic tka set unassigned - zinfo-01 - information fee unassigned - zoscl-01 - oscillator jav streaming oscillator unassigned - zream-01 - reamer h7: z-0021-20220.
Event or Problem Description
As reported, the patient had an initial left tka on (b)(6)2017.The patient complained of knee swelling and pain and the surgeon diagnosed the wear of the tibial insert, then revision surgery for the replacement of the tibial insert was performed.Breakage and wear was observed in the retrieved tibial insert.The surgeon did not find metallosis.He decided that no problem of the locking mechanism of the tibial tray was found and removed all proliferative tissue.There was no reported surgical delay/prolongation.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of a combination of knee instability and overall tibial slope that allowed for excessive posterior and medial contact leading to wear of the polyethylene tibial insert.A contributing factor to the extent of wear on insert may have been the result of being packaged in a non-conforming vacuum bag for five years.
Additional Manufacturer Narrative
Correction: h6 clinical code and component code.Additional information: h6 problem code.
Additional Manufacturer Narrative
Correction: h6 investigation conclusions.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely the result of a combination of knee instability and overall tibial slope that allowed for excessive posterior and medial contact leading to wear of the polyethylene tibial insert.A contributing factor to the extent of wear on insert may have been the result of being packaged in a non-conforming vacuum bag for five years.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
• 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: 17265611
• Report Number: 1038671-2023-01555
• Device Sequence Number: 8061516
• Product Code: JWH
• UDI-Device Identifier: 10885862174314
• UDI-Public: 10885862174314
• 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: 2017
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/27/2025

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: 11/18/2020
• Device Model Number: 02-012-49-2009
• 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: 06/16/2023
• Supplement Date Received by Manufacturer: 02/19/2024; 08/27/2024; 11/04/2024; 03/27/2025
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 03/05/2024; 09/04/2024; 11/08/2024; 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2012
• 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 H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 60 KG