MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CR TIB INSERT SLOPE++, SZ 4, 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	11/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately five years post initial right tka, the 56 y/o male patient was revised due to polyethelene wear and femoral loosening, as a result of osteolysis.The patient was revised to a logic cem ps femur size 4 and a size 4 tibial insert.There was breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Photos received.Sales rep was unable to obtain x-rays.The devices are not available for evaluation due to the devices were disposed at hospital.
Additional Manufacturer Narrative
Section d10: concomitant products.Logic cr femoral por, right, sz 4 (cat# 02-010-04-0340 / serial# (b)(6).Three peg patella 38mm (cat# 200-02-38 / serial# (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
The revision reported was likely the result of prosthesis wear, osteolysis, and an insufficient bond between the femoral component and the bone which led to aseptic (non-infected) femoral loosening.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The extent and root cause of the prosthesis wear, osteolysis, and femoral loosening could not be determined as the devices were not returned for evaluation, and radiographs were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: h6, the following sections were corrected: h6, h11.No device was returned for evaluation; photographs of the device were provided; however, the reported event was unable to be confirmed.The review identified that there appears to be evidence of third body wear on the articular surface of the tibial insert.Third body wear occurs when a third body, such as a fragment of bone or bone cement, gets trapped between the articulating surfaces of the tibial insert and femoral component.As the patient moves, the third body creates scratches, and sometimes pitting, on the surface of the tibial insert.The patella appears to have some scratching, and damage along the edge of the patella.Both damage patterns appear consistent with tool damage sustained during device removal.The retained bone adhered to the porous surface of the femoral component, which appears consistent with fixation between the femoral component and the patient¿s bone.The absence of bony ingrowth may be indicative of femoral loosening.However, this cannot be confirmed from the available information.Operative notes and/or medical records were not provided for review of usage/ technique.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, may have resulted from tibial insert prosthesis wear, osteolysis, and an insufficient bond between the femoral component and the bone which led to aseptic (non-infected) femoral loosening.The patella wear could not be confirmed from the provided information.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The extent and root cause of the prosthesis wear, osteolysis, and femoral loosening could not be determined as the devices were not returned for evaluation, and radiographs were not provided.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 4, 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: miguel soza
• MDR Report Key: 18467592
• Report Number: 1038671-2024-00037
• Device Sequence Number: 15233136
• Product Code: JWH
• UDI-Device Identifier: 10885862174512
• UDI-Public: 10885862174512
• 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: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/10/2023
• Device Model Number: LOGIC CR TIB INSERT SLOPE++, SZ 4, 9MM
• Device Catalogue Number: 02-012-49-4009
• 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: Not provided
• Supplement Date Received by Manufacturer: 03/20/2024; 10/17/2025
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 05/15/2024; 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2015
• 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: LGC TIBIAL FIT TRAY CEM SZ 4F / 4T.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male