MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Synovitis (2094); Insufficient Information (4580)
Date of Event	01/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Procode: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Concomitant medical products: serial #: (b)(4), category #: 02-010-04-0225 - logic femur cr poroso nº2.5 izq., serial #: (b)(4), category #: 02-012-45-2525 - bandeja tibial logic fit 2.5f/2.5t.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a 71 yo male patient, initial knee implanted on (b)(6) 2019, underwent a revision procedure on (b)(6) 2023, approximately 3 years 2 months post the initial procedure.The operating room supervisor called the rep to let them know that a knee had been checked for excessive wear of the polyethylene.The patient was last known to be in stable condition following the event.The device is available for return.No further information.
Event or Problem Description
The revision reported was likely the result of wear of the tibial insert.Contributing factors to the wear and delamination may have been implant positioning and being packaged in a non-conforming vacuum bag for more than five years.
Additional Manufacturer Narrative
H6 - health effect-clinical code, 4112 analyses of data provided by user/third party is no longer valid.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1/d2a/d2b, h6.Mdr section codes updated/corrected: b, c, d, g.The revision reported was likely the result of wear of the tibial insert.Contributing factors to the wear and delamination may have been implant positioning and being packaged in a non-conforming vacuum bag for more than five years.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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 ; 3523771140
• MDR Report Key: 16492598
• Report Number: 1038671-2023-00356
• Device Sequence Number: 12322145
• Product Code: JWH
• UDI-Device Identifier: 10885862159144
• UDI-Public: 10885862159144
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/14/2025

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: 08/30/2021
• Device Model Number: LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM
• Device Catalogue Number: 02-012-47-2509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 05/26/2023; 02/06/2024; 05/14/2025
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 06/01/2023; 11/06/2024; 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2013
• 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: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male