MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 5, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC TIB INSERT IMPL CRC, SZ 5, 11MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	10/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 2.5 years post initial right tka, the 72 y/o male patient was revised due to poly wear.The tibial insert component was revised from a size 5 11mm, to a size 5 13mm insert.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images received.Sales rep was unable to obtain x-rays.The device is not available for evaluation as the device was discarded by the hospital.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of prosthesis wear and prosthesis fracture.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.Additionally, a contributing factor to the prosthesis wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.The extent and root cause of the prosthesis wear and prosthesis fracture could not be determined as the device was not returned for evaluation, and radiographs were not provided.
Additional Manufacturer Narrative
Correction: h6 clinical code, h6 investigation findings, h6 investigation conclusions.

• Brand Name: LOGIC TIB INSERT IMPL CRC, SZ 5, 11MM
• 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: kate jacobson
• MDR Report Key: 18148541
• Report Number: 1038671-2023-02810
• Device Sequence Number: 15200613
• Product Code: JWH
• UDI-Device Identifier: 10885862230577
• UDI-Public: 10885862230577
• 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: 2021
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2021
• Device Model Number: LOGIC TIB INSERT IMPL CRC, SZ 5, 11MM
• Device Catalogue Number: 02-012-51-5011
• 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: 10/26/2023
• Supplement Date Received by Manufacturer: 12/11/2023; 11/04/2024
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 04/18/2024; 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2013
• 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
• 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: LGC TIBIAL FIT TRAY CEM SZ 5F / 5T.; LOGIC CR FEMORAL CEM, RIGHT, SZ 5.; THREE PEG PATELLA 41MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male