MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 3.5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	LOGIC TIB INSERT IMPL CRC, SZ 3.5, 9MM
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	08/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 62 yo male patient, initial left knee implanted on 10/17/2019, underwent a revision procedure on (b)(6) 2022, approximately 2 years 9 months post the initial procedure due to instability.The patient was last known to be stable following the event.
Additional Manufacturer Narrative
No device return anticipated due to it was disposed of by the customer.Concomitants: lgc tibial fit tray cem sz 3.5f / 4.5t 02-012-45-3545 sn: (b)(4), logic cr femoral por, left, sz 3.5 02-010-04-0235 sn: (b)(4), three peg patella 38mm 200-02-38 sn: (b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H6: based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the instability and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.H7: z-0021-2022.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, d1, h6 medical device problem code, component code, type of investigation, investigation findings, investigation conclusion codes.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: LOGIC TIB INSERT IMPL CRC, SZ 3.5, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3523771140
• MDR Report Key: 15421956
• Report Number: 1038671-2022-01115
• Device Sequence Number: 14092416
• Product Code: JWH
• UDI-Device Identifier: 10885862230447
• UDI-Public: 10885862230447
• 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: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• 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): 10/01/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: LOGIC TIB INSERT IMPL CRC, SZ 3.5, 9MM
• Device Catalogue Number: 02-012-51-3509
• 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: 08/16/2022
• Supplement Date Received by Manufacturer: 08/16/2022; 09/29/2025
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 09/24/2022; 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male