MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 2, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-49-2011
Medical Device Problem Codes	Crack (1135); Naturally Worn (2988)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Sepsis (2067); Swelling/ Edema (4577)
Date of Event	04/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 02-010-03-0220 - logic cr femoral cem, left sz 2: sn# (b)(6).02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t: sn# (b)(6).200-02-29 - three peg patella 29mm: sn# (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
As reported, approximately 10 years and 6 months post the initial left total knee arthroplasty, the patient presented to the hospital with sepsis.The knee was not really bothering the patient until they became sick with other ailments.The surgeon examined the left knee and saw stiffness from swelling, pain, and dissatisfaction with their total knee.The patient was scheduled for a revision of the left total knee arthroplasty, irrigation and debridement, with polyethylene swap vs.Antibiotic spacer placement.The patient was revised and underwent a tibial poly implant swap, and antibiotic beads were placed.Images provided show a crack and wear of the polyethylene.There was no reported breakage of a device, and a 15-30 minute surgical delay/prolongation.The patient did not experience any adverse events as a result.The patient was last known to be in stable condition following the event.

• Brand Name: LOGIC CR TIB INSERT SLOPE++, SZ 2, 11MM
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 24997153
• Report Number: 1038671-2026-00490
• Device Sequence Number: 9773965
• Product Code: JWH
• UDI-Device Identifier: 10885862174321
• UDI-Public: 10885862174321
• 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: 2015
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/27/2026

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: 03/05/2020
• Device Catalogue Number: 02-012-49-2011
• 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: 04/05/2026
• Initial Report FDA Received Date: 04/27/2026
• Date Device Manufactured: 03/06/2012
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female