MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 3, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	LOGIC CR TIB INSERT STD, SZ 3, 9MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	10/30/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Per a report from the legal department a female patient had a left knee on (b)(6) 2013.Approximately 4 years and 7 months after the initial procedure the patient had a left knee revision on (b)(6) 2017.Revision op report (b)(6) 2023/ k mcguinness received via legal 11 apr 2023.In the op report there was significant instability and catastrophic poly wear.The medial and lateral gutters were debrided of significant poly disease.Patient arrived in pacu in stable condition with no apparent complications.
Additional Manufacturer Narrative
D10: concomitants: serial #: (b)(4), category #: 203-96-22 - (11-3110) stryker 2000 90x19x 1.19mm, serial #: (b)(4), category #: 203-96-21 - (11-2714) stryker 2000 90x13/21x 1.9mm, serial #: (b)(4), category #: 02-010-03-0230 - logic cr femoral cem, left, sz 3, serial #: (b)(4), category #: 200-02-32 - three peg patella 32mm, serial #: (b)(4), category #: 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t.Pending investigation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and instability 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 CR TIB INSERT STD, SZ 3, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• 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 ; 3523771140
• MDR Report Key: 16833282
• Report Number: 1038671-2023-00857
• Device Sequence Number: 15249001
• Product Code: JWH
• UDI-Device Identifier: 10885862174345
• UDI-Public: 10885862174345
• 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: 2013
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/29/2019
• Device Model Number: LOGIC CR TIB INSERT STD, SZ 3, 9MM
• Device Catalogue Number: 02-012-47-3009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• 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
• Patient Age: 55 YR
• Patient Sex: Female