MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE+, SZ 5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	02-012-48-5009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	04/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: 3756746 02-010-04-0350 - logic cr femoral por, right, sz 5.3807243 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t.3967574 200-02-38 - three peg patella 38mm.4200659 201-78-15 - holding pin mini sharp point 4 pk.4069065 201-78-81 - 3 trocar, mod.Hex 2pk.4069078 201-78-81 - 3 trocar, mod.Hex 2pk.4069116 201-78-81 - 3 trocar, mod.Hex 2pk.3947329 521-78-23 - threaded pin size 2.3 collared.3947335 521-78-23 - threaded pin size 2.3 collared.4050659 521-78-23 - threaded pin size 2.3 collared.10020015031 a10012 - gps implant kit v2.10021015020 a10012 - gps implant kit v2.
Event or Problem Description
As reported, the patient had an initial right tka on (b)(6) 2016.The patient was revised on (b)(6) 2023 due to poly wear.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of prosthesis wear, as stated in the experience report.However, the reason for the wear could not be determined because the device was not returned for evaluation and images were not provided.

• Brand Name: LOGIC CR TIB INSERT SLOPE+, SZ 5, 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 66 court; gainesville FL 32653
• Manufacturer Contact: julia goldberg ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16915721
• Report Number: 1038671-2023-00972
• Device Sequence Number: 2252104
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/07/2026

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: 06/11/2022
• Device Model Number: 02-012-48-5009
• Device Catalogue Number: 02-012-48-5009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2023
• Supplement Date Received by Manufacturer: 07/14/2023; 07/07/2026
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 07/25/2023; 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2014
• 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: Male