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

Catalog Number	02-012-49-2509
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Aseptic loosening (4883)
Date of Event	08/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 7 years post op initial left tka, this 79 y/o female patient was revised due to poly wear.The femoral and tibial components are also loosening.All components were replaced with a revision knee system.Patient was last known to be in stable condition following the condition.No other patient information/medical history reported.Photos attached, unable to obtain x-rays.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation; (d10) concomitant device(s): (b)(6), 02-010-04-0225 - logic cr femoral por, left, sz 2.5; (b)(6), 02-012-45-2515 - lgc tibial fit tray cem sz 2.5f / 1.5t; (b)(6), 200-02-32 - three peg patella 32mm; (b)(6), 201-78-15 - holding pin mini sharp point 4 pk; (b)(6), 201-78-81 - 3 trocar, mod.Hex 2pk; (b)(6), 521-78-23 - threaded pin size 2.3 collared; (b)(6), 521-78-23 - threaded pin size 2.3 collared; (b)(6), 521-78-32 - threaded pin size 3.0 collarless; 10020015006, (b)(6) - gps implant kit v2; (b)(6), stk190-119-90 - stryker saw blade 90x19x1.19mm.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of prosthesis wear, prosthesis fracture, and insufficient bonds between the implants and the bones, which resulted in aseptic (non-infected) loosening.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The extent and root cause of the prosthesis wear, prosthesis fracture, and loosening could not be determined as the devices were not returned for evaluation, and radiographs were not provided.Section h11: *the following sections have corrected information: (h6) component code: 734, bearings.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, g2 (initial report-australia), h6: clinical code, types, findings and investigation conclusion.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 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 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17715958
• Report Number: 1038671-2023-02218
• Device Sequence Number: 16681681
• Product Code: JWH
• UDI-Device Identifier: 10885862159212
• UDI-Public: 10885862159212
• 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: 2016
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/31/2025

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: 06/06/2022
• Device Catalogue Number: 02-012-49-2509
• 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: 08/18/2023
• Supplement Date Received by Manufacturer: 12/08/2023; 12/26/2025
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 12/29/2023; 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2014
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female