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

Catalog Number	02-012-48-3509
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	11/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 4 years post op initial left tka, this 73 y/o female patient was revised due to poly wear and femur loosening.Patient was last known to be in stable condition following the event.Product not returning - disposed.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation; (d10) concomitant device(s): 5777031 - 02-010-04-0235 - logic cr femoral por, left, sz 3.5; 3933664 - 02-012-45-3525 - lgc tibial fit tray cem sz 3.5f / 2.5t; 5939545 - 200-02-35 - three peg patella 35mm; 5719606 - 201-78-15 - holding pin mini sharp point 4 pk; 5776148 - 201-78-81 - 3 trocar, mod.Hex 2pk; s019825 - 521-78-23 - threaded pin size 2.3 collared; s032419 521-78-23 - threaded pin size 2.3 collared; s031429 521-78-32 - threaded pin size 3.0 collarless; 6028019001 a10012 - gps implant kit v2.
Additional Manufacturer Narrative
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.The aseptic (non-infected) femoral loosening was likely the result of an insufficient bond between the femoral component and the bone.However, this cannot be confirmed because the revised components were not returned for evaluation and no radiographs were provided.
Additional Manufacturer Narrative
*the following sections have corrected information: (h6) type of investigation, investigation findings, investigation conclusions.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.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.The aseptic (non-infected) femoral loosening was likely the result of an insufficient bond between the femoral component and the bone.However, this cannot be confirmed because the revised components were not returned for evaluation and no radiographs were provided.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 3.5, 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 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18181908
• Report Number: 1038671-2023-02831
• Device Sequence Number: 7661640
• Product Code: JWH
• UDI-Device Identifier: 10885862159281
• UDI-Public: 10885862159281
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/05/2025

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: 12/17/2022
• Device Catalogue Number: 02-012-48-3509
• 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: 11/03/2023
• Supplement Date Received by Manufacturer: 02/27/2024; 10/07/2024; 05/05/2025
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 03/04/2024; 10/09/2024; 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2014
• 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.
• Patient Age: 73 YR
• Patient Sex: Female