MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 3, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-51-3009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) pending evaluation.(d10) concomitant device(s): (b)(6), 02-010-04-0330 - logic cr femoral por, right, sz 3.(b)(6), 02-012-45-3020 - lgc tibial fit tray cem sz 3f / 2t.(b)(6), 201-78-15 - holding pin mini sharp point 4 pk.(b)(6), 201-78-81 - 3 trocar, mod.Hex 2pk.(b)(6), 521-78-23 - threaded pin size 2.3 collared.(b)(6), 521-78-23 - threaded pin size 2.3 collared.(b)(6), 521-78-32 - threaded pin size 3.0 collarless.
Event or Problem Description
It was reported that this 67/ y/o female patient's right knee was revised 2 years 2 months post op.Everything was revised due to wear on patella and tibial insert.Everything was removed and replaced with the competitors device.Patient was last known to be in stable condition following the event.Product not returning: discarded at the hospital.
Additional Manufacturer Narrative
(h3) the revision reported may have been the result of prosthesis wear or due to inclusion of the polyethylene component in the packaging recall.Based on the images provided, there appears to minor damage on the articular surfaces of the tibial insert and patella component which does not appear inconsistent with implanted devices.However, this cannot be confirmed because the components were not returned for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported may have been the result of prosthesis wear or due to inclusion of the polyethylene component in the packaging recall.Based on the images provided, there appears to minor damage on the articular surfaces of the tibial insert and patella component which does not appear inconsistent with implanted devices.However, this cannot be confirmed because the components were not returned for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC TIB INSERT IMPL CRC, SZ 3, 9MM
• 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19943231
• Report Number: 1038671-2024-02750
• Device Sequence Number: 18000364
• Product Code: JWH
• UDI-Device Identifier: 10885862230409
• UDI-Public: 10885862230409
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2025

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 Catalogue Number: 02-012-51-3009
• 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: 07/22/2024
• Supplement Date Received by Manufacturer: 10/18/2024; 02/18/2025
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 11/07/2024; 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female