MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 3, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	02-020-13-0330
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The evaluation pending.Concomitant devices: logic tibial insert crc, size 3, 13mm: (cn: 02-012-51-3013, sn: (b)(4)); truliant tibial fit tray size 3f/3t: (cn: 02-022-45-3030, sn: (b)(4)); three peg patella: (cn: 200-07-32 , sn: (b)(4)).
Event or Problem Description
A (b)(6) y/o male patient called and stated approximately 18 months post op from the initial implant, he started having swelling, pain, knee felt unstable and worsened with time.The patient states the surgeon states the device had ¿came apart¿ and needed to be replaced.States he is doing well after the revision, but was more painful than recovering from the initial implant.Devices will not be returned put will send pics once he has received the devices.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted in the revision reported may have been the result of dislocation, detachment of the tibial insert from the tibial tray, or loosening of the femoral component and/or the tibial tray, which led to the persistent pain.The most likely underlying cause cannot be determined because the revised components were not returned for evaluation, no images or x-rays were provided, and limited information was supplied.(d11)concomitant devices: - logic tibial insert crc, size 3, 13mm: (cn: (b)(6), sn: (b)(6)) - truliant tibial fit tray size 3f/3t: (cn: (b)(6), sn: (b)(6)) - three peg patella: (cn: (b)(6), sn: (b)(6)).
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3/g4, h6.The following sections were corrected: d1/d2a/d2b, d4, h4, h6.Mdr section codes updated/corrected: b, c, d, g.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, tibial loosening, and femoral loosening, or due to 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 and images 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 TIB INSERT IMPL CRC, SZ 3, 13MM
• 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 66th ct.; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523782617
• MDR Report Key: 9985767
• Report Number: 1038671-2020-00278
• Device Sequence Number: 19807451
• Product Code: JWH
• UDI-Device Identifier: 10885862230423
• UDI-Public: 10885862230423
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2025

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: 01/15/2018
• Device Model Number: 02-020-13-0330
• Device Catalogue Number: 02-012-51-3013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 04/08/2020
• Supplement Date Received by Manufacturer: 08/14/2020; 02/11/2025
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 08/18/2020; 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 91 KG