MAUDE Adverse Event Report: EXACTECH, INC. LOGIC; SEE H10

Model Number	LOGIC TIBIAL INSERT SLOPE ++, SZ 2.5, 9 MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 56 yo female patient, initial right knee implanted on (b)(6) 2019, underwent a revision procedure on (b)(6) 2023, approximately 4 years 5 months post the initial procedure.The patient was revised due to patella wear and the delamination of the tibial insert.The liner and patella were exchanged.There were no surgical delays or device breakages during the procedure.The patient was last known to be stable following the event.No x-rays or imaging was available.The product is not available for return as it was disposed of by the hospital.Device images were provided.No other patient information/medical history reported.No further information.
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer d10: concomitants: 5737675 - 02-010-04-0325 - logic cr femoral por, right, sz 2.5 5679574 - 2-012-45-2525 - lgc tibial fit tray cem sz 2.5f / 5t 5687943 - 200-02-35 - three peg patella 35mm 5967721 - 201-78-15 - holding pin mini sharp point 4 pk 5776339 - 201-78-81 - 3 trocar, mod.Hex 2pk 5440259 - 521-78-23 - threaded pin size 2.3 collared s011724 - 521-78-23 - threaded pin size 2.3 collared s017711 - 521-78-32 - threaded pin size 3.0 collarless 2029019123 ¿ (b)(6) - gps implant kit v2 6 additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
The revision reported was likely the result of prosthesis wear of the tibial insert secondary to instability and patient-related issues.Instability of the knee may have allowed for excessive posterior and medial contact leading to full-thickness wear of the polyethylene tibial insert.A contributing factor to the wear on the tibial insert may have been result of being packaged in a non-conforming vacuum bag for more than five years.There does not appear to be a wear issue with the explanted patella.However, this cannot be confirmed as the devices were not returned for evaluation.

• Brand Name: LOGIC
• Common Device Name: SEE H10
• 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: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18476365
• Report Number: 1038671-2024-00047
• Device Sequence Number: 6407568
• Product Code: JWH
• UDI-Device Identifier: 10885862159212
• UDI-Public: 10885862159212
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/26/2022
• Device Model Number: LOGIC TIBIAL INSERT SLOPE ++, SZ 2.5, 9 MM
• Device Catalogue Number: 02-012-49-2509
• 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: 12/11/2023
• Supplement Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 04/15/2024
• Date Device Manufactured: 03/28/2014
• 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: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female