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

Model Number	LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 9 MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Metal Related Pathology (4530)
Date of Event	06/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately four years post initial right tka, the male patient needed to be revised to a full revision knee due to poly wear and metallosis.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Photos received.Sales rep was unable to obtain x-rays.The devices are not available for evaluation as they were discarded at the hospital.
Additional Manufacturer Narrative
Section d10: concomitant products: lgc tibial fit tray cem sz 3.5f / 3.5t (cat# 02-012-45-3535 / serial# (b)(6)), logic cr femoral por, right, sz 3.5 (cat# 02-010-04-0335 / serial# (b)(6)), three peg patella 41mm (cat# 200-02-41 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the revision reported was likely the result of the overall posterior slope of the tibial insert, which would allow for excessive posterior contact on the tibial insert and lead to wear of the polyethylene and direct femoral component-tibial tray contact.However, this cannot be confirmed because no radiographs were provided, and the revised components were not returned to exactech for evaluation.Additionally, a contributing factor to the tibial insert wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.The most probable root cause associated with the reported event of ¿prosthesis wear¿ is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.H3: operative notes and/or medical records were not provided for review of usage/ technique.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, radiograph images were not provided for review.The revision reported in was likely the result of the overall posterior slope of the tibial insert, which would allow for excessive posterior contact on the tibial insert and lead to wear of the polyethylene and direct femoral component-tibial tray contact.However, this cannot be confirmed because no radiographs were provided and the revised components were not returned to exactech for evaluation.Additionally, a contributing factor to the tibial insert wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and radiographs and relevant clinical information were not provided.

• Brand Name: LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 9 MM
• 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 ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17308011
• Report Number: 1038671-2023-01625
• Device Sequence Number: 20648332
• Product Code: JWH
• UDI-Device Identifier: 10885862159311
• UDI-Public: 10885862159311
• 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
• 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): 03/04/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• 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: 06/27/2023
• Supplement Date Received by Manufacturer: 06/27/2023; 03/03/2025
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 10/31/2023; 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male