MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-3009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/25/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that the patient was implanted with an optetrak logic device on the right knee and then approximately 10 years later the patient was revised.There was no other patient/medical information provided.No x-rays or images were provided.There is no device return.There is no other information available.
Additional Manufacturer Narrative
H11.D10.Concomitants - product information: 3581943 - 02-010-01-0330 - logic femoral ps cem right sz 3; 3573900 - 02-012-45-3020 - lgc tibial fit tray cem sz 3f / 2t; aa7707 - 1510-s - cemex system fast 70 gm; 3559103 - 200-02-35 - three peg patella 35mm pending investigation.There is no other information available.
Additional Manufacturer Narrative
H6: corrected the following: component code, type of investigation, investigation findings, investigation conclusions.The reason for the revision reported cannot be confirmed from the information provided but may have been reported at this later time due to inclusion of one of the implanted devices in the packaging recall.However, the reported prosthesis wear/failure could not be confirmed and potential contributions of user or patient-related considerations to the event could not be assessed as no images or radiographs were provided, relevant clinical information was not provided and the devices were not available for evaluation.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 3 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 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 19602181
• Report Number: 1038671-2024-02098
• Device Sequence Number: 16976146
• Product Code: JWH
• UDI-Device Identifier: 10885862001801
• UDI-Public: 10885862001801
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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: 11/29/2019
• Device Catalogue Number: 02-012-35-3009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2011
• 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: Required Intervention
• Patient Sex: Unknown