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

Catalog Number	02-012-35-2509
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10.Pending investigation.There is no other information provided.
Event or Problem Description
It was reported via legal documentation that a patient had a left knee arthroplasty on (b)(6) 2014, and then experienced a revision surgical procedure on (b)(6) 2022, approximately 7 years, 11 months after initial implant.There was no other patient/medical information provided.No x-rays or images were provided.The device will not be returned.There is no other information available.
Additional Manufacturer Narrative
D4: added catalog number, expiration date, serial number, and udi d10: (b)(6) 204-04-21 - trapezoid tibial tray sz 1f/1t, 2f/1t.(b)(6) 204-34-12 - fluted stem extension 120l x 14 mm.(b)(6) 02-010-01-0225 - logic femoral ps cem left sz 2.5.(b)(6) 200-02-32 - three peg patella 32mm.(b)(6) 208-09-05 - cc stem ext adaptor 5 degree.(b)(6) 200-02-32 - three peg patella 32mm.(b)(6) 02-012-45-2515 - lgc tibial fit tray cem sz 2.5f / 1.5t.(b)(6) 204-30-12 - stem extension 120l x10 mm.(b)(6) 208-01-02 - cc femoral sz 2.(b)(6) 204-34-02 - fluted stem extension 25l x 14 mm.(b)(6) 204-70-00 - tibial stem ext.Screw.(b)(6) 208-22-15 - cc tibial insert sz 2, 15mm.G3: added 510k number.H4: added device manufacture date.H6: corrected health effect - clinical code, component code, type of investigation, investigation findings, and investigation conclusions.Manufacturer narrative updated: the reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear or due to inclusion of the polyethylene in the packaging recall.However, the reported prosthesis wear could not be confirmed and 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.

• 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: geoff gannon
• MDR Report Key: 19353229
• Report Number: 1038671-2024-01344
• Device Sequence Number: 18019827
• Product Code: JWH
• UDI-Device Identifier: 10885862001764
• UDI-Public: 10885862001764
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• 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): 09/26/2024

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: 12/05/2021
• Device Catalogue Number: 02-012-35-2509
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2013
• 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.; UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown