MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 9 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 9 MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	07/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 5 years post op initial right tka, this female patient was revised due to poly wear.All implants were removed due to excessive bone lost.Patient was last known to be in stable condition following the event.No other patient information/medical history reported.Photos attached.Unable to obtain x-rays.Product not returning - disposed.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.(d10) concomitant device(s): 5107492 02-010-04-0335 - logic cr femoral por, right, sz 3.5.5145565 02-012-45-3535 - lgc tibial fit tray cem sz 3.5f / 3.5t.5265734 200-02-35 - three peg patella 35mm.5192219 201-78-15 - holding pin mini sharp point 4 pk.5249133 201-78-81 - 3 trocar, mod.Hex 2pk.5118180 521-78-23 - threaded pin size 2.3 collared.5118204 521-78-23 - threaded pin size 2.3 collared.5222326 521-78-32 - threaded pin size 3.0 collarless.2021018080 a10012 - gps implant kit v2.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of prosthesis wear, prosthesis fracture, and osteolysis.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.This prosthesis wear, in combination with the axial rotational mismatch, likely led to the prosthesis fracture.The extent and root cause of the prosthesis wear, prosthesis fracture, and osteolysis could not be determined as the device was not returned for evaluation, and radiographs were not provided.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 additional and/or corrected information.The revision reported was likely the result of prosthesis wear.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and radiographs and relevant clinical information was 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 3.5, 9 MM
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17642048
• Report Number: 1038671-2023-02079
• Device Sequence Number: 15448391
• Product Code: JWH
• UDI-Device Identifier: 10885862159311
• UDI-Public: 10885862159311
• 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: 2018
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/07/2025

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: 06/17/2022
• Device Model Number: LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 9 MM
• Device Catalogue Number: 02-012-49-3509
• 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: 08/10/2023
• Supplement Date Received by Manufacturer: 12/06/2023; 03/04/2025
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 12/29/2023; 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2014
• 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
• 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: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female