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

Model Number	02-012-49-1009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Swelling/ Edema (4577)
Date of Event	09/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 3 years post op the initial left tka, this 71 y/o female patient was revised due to wear of the tibial insert.The patient was experiencing knee swelling and pain.Breakage and wear were observed on the retrieved tibial insert.The surgeon decided that there was no problem found on the locking mechanism of the tibial tray, and after removing all proliferative tissues, only the insert was replaced.Device is not retuning, device is given to patient.
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 2160093, 02-010-03-0210 - logic cr cement femoral left, 1; 4828295, 02-012-45-1010 - logic fit cement tivial tray 1f/1t; 4000019040, a10012 - gps disposable kit; 993320, tn190-119-05 - oscillating blade m-class 19x1.19x105; 1017596, tn193-119-90 - oscillator blade m-class 19/13x 1.19x90mm; unassigned, z99007 - logic tka set; unassigned, zinfo-01 - information provision fee; unassigned, zoscl-01 - oscillator; unassigned, zream-01 - reamer.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of wear of the tibial insert, which led to the patient¿s pain.A contributing factor to the severity of the wear and delamination may have been result of being packaged in a non-conforming vacuum bag for more than five years.Section h11: the following sections have corrected information: (h6) component code: 4316, appropriate term/code not available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, d8, g1, h6 - health effect - clinical code, type of investigation, investigation findings, investigation conclusions, h7 and h11.The revision reported was likely the result of wear of the tibial insert, which led to the patient¿s pain.A contributing factor to the severity of the wear and delamination may have been result of being packaged in a non-conforming vacuum bag for more than five years.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 1, 9MM
• 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 court; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66th ct; gainesville, FL ; 3523771140
• MDR Report Key: 15708061
• Report Number: 1038671-2022-01380
• Device Sequence Number: 4932600
• 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: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2026

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: 08/18/2024
• Device Model Number: 02-012-49-1009
• Device Catalogue Number: 02-012-49-1009
• 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: 10/12/2022
• Supplement Date Received by Manufacturer: 02/23/2023; 03/23/2026
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 03/17/2023; 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2012
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 42 KG