MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 4, 13MM; SEE H10

Model Number	LOGIC CR TIB INSERT SLOPE++, SZ 4, 13MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	08/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer d10: concomitants: 4499846 02-010-03-0340 - logic cr femoral cem, right, sz 4, 4589416 02-012-45-4030 - lgc tibial fit tray cem sz 4f / 3t, 4560084 200-02-29 - three peg patella 29mm.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported a 65 yo female patient, initial right knee implanted on (b)(6) 2016, underwent a revision procedure on (b)(6) 2023, approximately 6 years 9 months post the initial procedure.The patient presented to the surgeon¿s office with complaints of pain, swelling, instability, and dissatisfaction with their tka.The patient has a recalled implant.Upon examination, the patient was scheduled to have a revision tka possible poly swap vs full knee revision.The tibial insert and the patella were revised.There was no breakage of device or surgical delay/prolongation reported.The patient was last known to be in stable condition following the event.The devices are not returning for evaluation.They were sent to the hospital lab and legal department.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b3, d1, h6.Mdr section codes updated/corrected: a, b, c, d, e, g.The reason for the reported event is likely the result of instability and inclusion of the tibial insert in the packaging recall.Prosthesis wear of the polyethylene components could not be confirmed from the provided information.Potential contributions of user, and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, relevant clinical information, and product information were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported a female patient, initial right knee implanted on and then underwent a revision procedure approximately 6 years 9 months post the initial procedure.The patient presented to the surgeon¿s office with complaints of pain, swelling, instability, and dissatisfaction with their tka.The patient has a recalled implant.Upon examination, the patient was scheduled to have a revision tka possible poly swap vs full knee revision.The tibial insert and the patella were revised.There was no breakage of device or surgical delay/prolongation reported.The patient was last known to be in stable condition following the event.The devices are not returning for evaluation.They were sent to the hospital lab and legal department.No further information.

• Brand Name: LOGIC CR TIB INSERT SLOPE++, SZ 4, 13MM
• Common Device Name: SEE H10
• 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: geoff gannon ; 3523771140
• MDR Report Key: 17807411
• Report Number: 1038671-2023-02358
• Device Sequence Number: 15135420
• Product Code: JWH
• UDI-Device Identifier: 10885862174536
• UDI-Public: 10885862174536
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 09/17/2025

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: 03/12/2020
• Device Model Number: LOGIC CR TIB INSERT SLOPE++, SZ 4, 13MM
• Device Catalogue Number: 02-012-49-4013
• 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: 09/01/2023
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2012
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 103 KG