MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK CLASSIC TIBIAL INSERT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	204-24-13
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11.Pending investigation.There is no other information provided.
Event or Problem Description
It was reported via legal documentation that the patient was implanted with an optetrak classic device on the right knee, with no revision surgery reported.There was no other patient/medical information provided.No x-rays or images were provided.There is no other information available.
Additional Manufacturer Narrative
D4: corrected d10: concomitant devices (b)(6) 200-02-41 - three peg patella 41mm (b)(6) 02-010-01-0240 - logic femoral ps cem left sz 4 (b)(6) 02-012-45-4030 - lgc tibial fit tray cem sz 4f / 3t (b)(6) 02-012-35-4009 - logic tibia ps mod insrt sz 4 9mm (b)(6) 204-70-00 - tibial stem ext.Screw (b)(6) 204-34-02 - fluted stem extension 25l x 14 mm h6: corrected the following: component code, type of investigation, investigation findings, investigation conclusions.Manufacturer narrative updated: the reason for the reported event cannot be confirmed from the information provided but may be due to prosthesis wear and/or inclusion of the polyethylene in the packaging recall.Potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.
Additional Manufacturer Narrative
D10: correction: concomitant devices: (b)(6) 204-04-44 - trapezoid tibial tray sz 4f/4t.(b)(6) 204-70-00 - tibial stem ext.Screw.(b)(6) 204-34-02 - fluted stem extension 25l x 14 mm.(b)(6) 200-02-41 - three peg patella 41mm.

• Brand Name: OPTETRAK CLASSIC TIBIAL INSERT
• 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: 19630292
• Report Number: 1038671-2024-02203
• Device Sequence Number: 8610522
• Product Code: JWH
• UDI-Device Identifier: 10885862048400
• UDI-Public: 10885862048400
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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,Followup
• Report Date (Section B): 10/03/2024

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: 03/11/2019
• Device Catalogue Number: 204-24-13
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2024
• Supplement Date Received by Manufacturer: 10/02/2024; Not provided
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 10/03/2024; 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2011
• 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 H10.; SEE H10.; UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown