MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; SEE H10

Model Number	CC TIBIAL INSERT SZ 5, 13MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via a legal notification that a 65 yo patient, initial left knee implanted on (b)(6) 2014, underwent a revision procedure on (b)(6) 2022, approximately 8 years post the initial procedure.The patient had been seen by the surgeon in an outpatient clinic.The patient had constant pain and instability that failed conservative treatment.The pre-procedure diagnosis indicated aseptic loosening of components and arthroplasty wear of the polyethylene liner.The polyethylene was removed with an osteotome without difficulty.The femoral component was noted to be grossly loose and was dis-impacted without difficulty.The tibial component was noted to be grossly loose and was dis-impacted off the tibial plateau without difficulty and there was minimal bone loss.The tibial stem and bone cement were removed.Competitor¿s devices were re-implanted.The patient was transferred to the post anesthesia care unit in stable condition with stable vital signs having tolerated the procedure well without apparent complications.No device returns anticipated due to this being a legal case.No further information.
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.D10: concomitants: serial #:(b)(4), category #: 204-04-55 - trapezoid tibial tray sz 5f/5t; serial #: (b)(4), category #: 200-02-35 - three peg patella 35mm; serial #: (b)(4), category #: 204-34-08 - fluted stem extension 80l x 14 mm; serial #: (b)(4), category #: 204-38-12 - stem extension w/slot 120l x18 mm; serial #: (b)(4), category #: 208-09-05 - cc stem ext adaptor 5 degree; serial #: (b)(4), category #: 208-01-05 - cc femoral sz 5; serial #: (b)(4), category #: 1510-s - cemex system fast 70 gm.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H6: corrected the following: health effect clinical code, medical device problem code, component code, type of investigation, investigation findings, investigation conclusions the reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, femoral loosening, and tibial loosening or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.

• Brand Name: OPTETRAK LOGIC
• Common Device Name: SEE H10
• 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: kate jacobson ; 3523771140
• MDR Report Key: 16758731
• Report Number: 1038671-2023-00713
• Device Sequence Number: 19599012
• Product Code: JWH
• UDI-Device Identifier: 10885862054425
• UDI-Public: 10885862054425
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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: 12/16/2017
• Device Model Number: CC TIBIAL INSERT SZ 5, 13MM
• Device Catalogue Number: 208-25-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2023
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2013
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0019-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male