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

Catalog Number	02-012-35-3013
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849)
Date of Event	11/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It is reported via legal documentation that a patient had a right total knee arthroplasty on (b)(6) 2019, with no revision surgery reported.There is no device information provided.No radiographic images of the device are provided.There is no other information available.
Additional Manufacturer Narrative
There is no additional information.Pending investigation.
Additional Manufacturer Narrative
D4: added catalog number, expiration date, serial number, and udi.D10: (b)(6) 02-010-01-0330 - logic femoral ps cem right sz 3.(b)(6) 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t.(b)(6) 200-07-32 - advanced patella 32mm 3 peg implant.G3: added 510k number.H4: added device manufacture date.H6: corrected health effect - clinical code, health effect - impact code, component code, type of investigation, investigation findings, and investigation conclusions.Manufacturer narrative updated: the reason for the prosthesis wear reported cannot be confirmed from the information provided but may be related to inclusion of the polyethylene in the packaging recall.Potential contributions of manufacturing, 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.

• Brand Name: OPTETRAK LOGIC 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: michael crader
• MDR Report Key: 18938699
• Report Number: 1038671-2024-00580
• Device Sequence Number: 15214457
• Product Code: JWH
• UDI-Device Identifier: 10885862001825
• UDI-Public: 10885862001825
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

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
• Device Expiration Date: 04/15/2024
• Device Catalogue Number: 02-012-35-3013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2023
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2016
• 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): Yes
• 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