MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 1, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	LOGIC CR TIB INSERT SLOPE++, SZ 1, 9MM
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately thirty months postop the initial right tka, the (b)(6) y/o female patient complained knee swelling and pain, the surgeon diagnosed the wear of the tibial insert, then revision surgery for the replacement of the tibial insert was performed.Breakage and wear were observed in the retrieved tibial insert.Removing all proliferative issues, the insert was replaced to new one.The surgeon judged that there is no problem with the stability of the tibial tray and the locking mechanism of the tibial tray for tibial insert fixation, the insert was replaced to 9mm thickness of size 1 cr neural tibial insert.
Additional Manufacturer Narrative
The evaluation noted that revision reported was likely the result of prosthesis wear due to a combination of third body wear, rotational mismatch between the femoral and tibial components, excessive posterior slope of the tibial components, and/or excessive flexion of the femoral component.The most probable root cause 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
After further review of additional information received the following sections d4, g4, g7 and h2 have been updated accordingly.Additional information, including the product investigation, will be submitted within 30 days of receipt.

• Brand Name: LOGIC CR TIB INSERT SLOPE++, SZ 1, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11163060
• Report Number: 1038671-2021-00005
• Device Sequence Number: 846903
• Product Code: JWH
• UDI-Device Identifier: 10885862174208
• UDI-Public: 10885862174208
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2021

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: 05/14/2022
• Device Model Number: LOGIC CR TIB INSERT SLOPE++, SZ 1, 9MM
• Device Catalogue Number: 02-012-49-1009
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 01/21/2021; 02/19/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 02/08/2021; 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 87 YR
• Patient Weight: 46