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); Insufficient Information (4580)
Date of Event	07/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant device(s): (b)(6), 02-010-03-0325 - logic cr femoral cem, right, sz 2.5.(b)(6), 02-012-45-2525 - lgc tibial fit tray cem sz 2.5f / 5t.(b)(6), 200-02-35 - three peg patella 35mm.(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.8012018106 a10012 - gps implant kit v2.
Event or Problem Description
As reported, approximately 4 years post op initial right tka, this 78 y/o female patient was revised due to poly wear.Liner and patella were exchanged.Patient was last known to be in stable condition following the event.No other patient information/medical history reported.Unable to obtain x-rays.Product not returning - disposed.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of prosthesis wear.A contributing factor to the extent of wear on the tibial insert may have been the result of being packaged in a non-conforming bag for more than 5 years.However, this cannot be confirmed as the device was not returned for evaluation and additional information regarding patient-related conditions or other contributing factors was 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 additional and/or corrected information.The revision reported was likely the result of prosthesis wear.A contributing factor to the extent of wear on the tibial insert may have been the result of being packaged in a non-conforming bag for more than 5 years.However, this cannot be confirmed as the device was not returned for evaluation and additional information regarding patient-related conditions or other contributing factors was not 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 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: 17646555
• Report Number: 1038671-2023-02088
• Device Sequence Number: 18126812
• 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: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2025

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: 09/12/2021
• 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: 08/11/2023
• Supplement Date Received by Manufacturer: 12/04/2023; 02/13/2025
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 12/19/2023; 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2013
• 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: Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female