MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 2 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	02-012-35-2015
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: 6376767 200-02-32 - three peg patella 32mm.H7: z-0021-2022.
Event or Problem Description
As reported, the patient had a previous poly swap on (b)(6) 2021.The patient was revised again on (b)(6) 2023 due to severe poly wear.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.
Additional Manufacturer Narrative
H3: the revision reported may have been the result of third body wear, malalignment between the femoral and tibial components, instability, patient-related conditions, the off-label use addressed in the user-related issues section above, or any combination of these possibilities, which led to polyethylene wear of the tibial insert.Additionally, a contributing factor to the reported wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.However, this cannot be confirmed as the device was not returned for evaluation, and images of the explanted device and radiographs were unable to be obtained.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of prosthesis wear.Contributing factors may have been instability, implant positioning, patient related conditions, the off label use documented in the user related issues, being packaged in a non-conforming vacuum bag for over five years, or any combination of these possibilities.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: d8.The following sections were corrected: b2, h6.The revision reported was likely the result of prosthesis wear.Contributing factors may have been instability, implant positioning, patient related conditions, the off label use documented in the user related issues above, being packaged in a non-conforming vacuum bag for over five years, or any combination of these possibilities.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 2 15MM
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17253181
• Report Number: 1038671-2023-01524
• Device Sequence Number: 5184002
• Product Code: JWH
• UDI-Device Identifier: 10885862001757
• UDI-Public: 10885862001757
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/10/2025

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: 03/03/2023
• Device Model Number: 02-012-35-2015
• Device Catalogue Number: 02-012-35-2015
• 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: 06/14/2023
• Supplement Date Received by Manufacturer: 08/24/2023; 01/09/2024; 01/09/2025
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 09/07/2023; 01/10/2024; 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2015
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female