MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE ++, SZ 1.5, 13 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	02-012-49-1513
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	03/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: serial #: (b)(6), catalog #: 02-010-03-0215 - logic cr femoral cem, left sz 1.5, serial #: (b)(4), catalog #: 02-012-45-1515 - lgc tibial fit tray cem sz 1.5f / 1.5t, serial #: (b)(6), catalog #: 200-02-29 - three peg patella 29mm.Correction/removal number: z-0021-2022.
Event or Problem Description
As reported, the patient had an initial left tka on (b)(6) 2017.The patient returned with complaints, including pain and dissatisfaction.The patient underwent a poly swap on (b)(6)2023 and was revised to a size 15mm crc poly, sz 1.5.Pieces of poly were removed from the patient's wound site.There was no reported surgical delay/prolongation.
Additional Manufacturer Narrative
H3: the revision reported was likely the combination of the slope ++ tibial insert and the positioning of the femoral components relative to the tibial components which allowed for excessive posterior contact between the femoral component and the tibial insert, especially laterally, and led to the observed wear of the polyethylene and pain.Additionally, a contributing factor to the wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.However, this cannot be confirmed as the device was not available for evaluation and a lateral pre-revision radiograph was not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b5, d8, g1, h2, h3, h6 clinical code, medical device problem code, component code, type of investigation, investigation findings, investigation conclusion codes.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
As reported, the patient had an initial left tka.The patient returned with complaints, including pain and dissatisfaction.The patient underwent a poly swap and was revised to a size 15mm crc poly, sz 1.5.Pieces of poly were removed from the patient's wound site.There was no reported surgical delay/prolongation.

• Brand Name: LOGIC CR TIB INSERT SLOPE ++, SZ 1.5, 13 MM
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16643953
• Report Number: 1038671-2023-00549
• Device Sequence Number: 5340237
• Product Code: JWH
• UDI-Device Identifier: 10885862144423
• UDI-Public: 10885862144423
• 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: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/13/2026

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: 08/11/2019
• Device Model Number: 02-012-49-1513
• Device Catalogue Number: 02-012-49-1513
• 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: 03/06/2023
• Supplement Date Received by Manufacturer: 08/03/2023; 01/30/2026
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 08/17/2023; 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2011
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 97 KG