MAUDE Adverse Event Report: EXACTECH, INC. Logic Knee Components; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	02-012-51-5009
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	07/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: three peg patella 38mm - 200-02-38 -(b)(6) lgc tibial fit tray cem sz 5f / 5t - 02-012-45-5050 - (b)(6), logic cr femoral por, left, sz 5 - 02-010-04-0250 - (b)(6), three peg patella 41mm - 200-02-41 - (b)(6), logic cr femoral cem, right, sz 5 - 02-010-03-0350 - (b)(6), logic tib insert impl crc, sz 5, 9mm - 02-012-51-5009 - (b)(6), lgc tibial fit tray cem sz 5f / 5t - 02-012-45-5050 - (b)(6).H7: z-0021-2022.
Event or Problem Description
As reported, this is the 3rd revision for this patient's right knee.The poly liner was exchanged twice before due to wear.As multiple revision surgeries were done unfortunately risk increases.The patient was revised on (b)(6) 2023 due to infection.A new femoral component and liner were implanted.Cement was utilized for tibia and patella.There was no reported breakage of a device or surgical delay / prolongation.The patient was last known to be in stable condition following the event.No other patient information / medical history reported.
Additional Manufacturer Narrative
H3: based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues; no device information was provided.The cause of the patient¿s infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.

• Brand Name: Logic Knee Components
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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: julia goldberg ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17368336
• Report Number: 1038671-2023-01737
• Device Sequence Number: 11728364
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 02-012-51-5009
• Device Catalogue Number: 02-012-51-5009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2023
• Supplement Date Received by Manufacturer: 12/14/2023; 07/24/2026
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 12/15/2023; 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2020
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male