MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 1.5, 9 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-47-1509
Medical Device Problem Codes	Crack (1135); Naturally Worn (2988)
Health Effect - Clinical Codes	Abdominal Pain (1685); Failure of Implant (1924); Pain (1994)
Date of Event	11/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient presented to surgeons office with pain.Significant poly wear was noted with exchange.No issues with surgery.Explant not available.No further information.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation (d10) concomitant device(s): (b)(6), 02-010-03-0215 - logic cr femoral cem, left sz 1.5.(b)(6) 02-010-03-0315 - logic cr femoral cem, right, sz 1.5.(b)(6) 02-012-45-1515 - lgc tibial fit tray cem sz 1.5f / 1.5t.(b)(6) 02-012-45-1515 - lgc tibial fit tray cem sz 1.5f / 1.5t.(b)(6) 200-02-32 - three peg patella 32mm.(b)(6) 200-02-32 - three peg patella 32mm.(b)(6) 201-46-10 - holding pin headless 3" (4 pk).
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.This may have been potentially caused from instability and malalignment of either the femoral and/or tibial component but cannot be confirmed from the provided images and provided radiographs.Additional reasons for the reported revision may be inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.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 STD, SZ 1.5, 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 ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18265660
• Report Number: 1038671-2023-02906
• Device Sequence Number: 3955952
• Product Code: JWH
• UDI-Device Identifier: 10885862144331
• UDI-Public: 10885862144331
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• 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): 04/01/2025

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: 06/01/2019
• Device Catalogue Number: 02-012-47-1509
• 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: 11/13/2023
• Supplement Date Received by Manufacturer: 03/31/2025; 03/31/2025
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 04/01/2025; 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2015
• 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
• Patient Sex: Unknown