MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 9 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 9 MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 3622126, 02-010-03-0335 - logic cr femoral cem, right, sz 3.5.3723074, 02-012-45-3535 - lgc tibial fit tray cem sz 3.5f / 3.5t.3777688, 200-02-35 - three peg patella 35mm.Pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a right knee replacement on (b)(6) 2015.Approximately 8 years and 3 months after the initial procedure the patient had a right knee revision on (b)(6) 2023.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Revision op report on (b)(6) 2023: diagnosis: failed tibial insert right knee.There was significant amount of synovitis and an effusion.There was symmetric wear posteriorly on both the medial and lateral aspect of the insert.There was obvious delamination.It was worse medially than laterally.There was no loosening or any osteolysis.There is no evidence of infection and the joint fluid had a string sign and was also sent out for culture.The patient was then transferred to gurney and taken to the recovery room.No complications.
Additional Manufacturer Narrative
Correction- this event is discovered to be a duplicate case and has been reported in mfr #1038671-2023-00979.All new and/or additional information will be submitted in mfr #1038671-2023-00979.

• Brand Name: LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 9 MM
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17443071
• Report Number: 1038671-2023-01839
• Device Sequence Number: 19510960
• Product Code: JWH
• UDI-Device Identifier: 10885862159311
• UDI-Public: 10885862159311
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2024

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: 02/27/2020
• Device Model Number: LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 9 MM
• Device Catalogue Number: 02-012-49-3509
• 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: 07/03/2023
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2012
• 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: A
• 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