MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE+, SZ 5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CR TIB INSERT SLOPE+, SZ 5, 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	10/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately six years post initial right tka, the 69 y/o male patient had a revision due to poly wear.All implants were removed.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 devices are not available for evaluation as they were discarded by the hospital.
Additional Manufacturer Narrative
Section d10: concomitant products logic cr femoral por, right, sz 5 (cat#: 02-010-04-0350 / serial#: (b)(6).Lgc tibial fit tray cem sz 5f / 4t (cat# 02-012-45-5040 / serial#: (b)(6).Three peg patella 38mm (cat#: 200-02-:38 / 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 g1, g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the revision reported was likely the result of presumed prosthesis wear of the tibial insert.However, images of the revised insert do not show signs of excessive prosthesis wear inconsistent with being implanted, no radiographs were provided, and the revised components were not returned to exactech for evaluation.The most probable root cause for 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 additional and/or corrected information.The following sections were corrected: h6.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 SLOPE+, SZ 5, 9MM
• 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: matt collins
• MDR Report Key: 18145211
• Report Number: 1038671-2023-02796
• Device Sequence Number: 17863433
• Product Code: JWH
• UDI-Device Identifier: 10885862174581
• UDI-Public: 10885862174581
• 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: 2017
• 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): 12/13/2024

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: 11/16/2023
• Device Model Number: LOGIC CR TIB INSERT SLOPE+, SZ 5, 9MM
• Device Catalogue Number: 02-012-48-5009
• 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: Not provided
• Supplement Date Received by Manufacturer: 01/23/2024; 12/13/2024
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 05/01/2024; 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2015
• 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
• 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 Age: 69 YR
• Patient Sex: Male