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

Model Number	CC TIBIAL INSERT SZ 3, 15MM
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	06/16/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal notification, that patient, underwent initial left knee replacement surgery on (b)(6) 2007.She was implanted with an optetrak device.On (b)(6) 2017, approximately 10 years 2 month post initial procedure, plaintiff underwent left total knee revision surgery due to a ¿left knee aseptic loosening.¿ upon removal of the original tibial insert, plaintiff was implanted with a second recalled optetrak device in her left knee.Plaintiff¿s revision surgery was due to accelerated and preventable wear of the defective polyethylene insert component within the optetrak device.Following her revision surgery, plaintiff continued to experience pain in her left knee, and plaintiff will be proceeding with a re-revision surgery to remove the second recalled optetrak device implanted in her left knee.No device return anticipated due to this being a legal case.No further information.
Additional Manufacturer Narrative
Prosthesis, knee, patellofemoral tibial, semi-constrained, cemented, polymer/metal/polymer.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H6: investigation results - the revision reported was likely the result of loosening and prosthesis wear as stated in the legal documentation.The aseptic (non-infected) loosening may have been the result of an insufficient bond between the implant and the bone.The extent and root cause of the reported polyethylene wear cannot be determined as the device was not returned for evaluation and radiographs, photographs, and operative notes were not provided.H6 clinical and problem codes were corrected to more accurately reflect the reported incident.

• Brand Name: OPTETRAK CC
• 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: 16422298
• Report Number: 1038671-2023-00210
• Device Sequence Number: 14838573
• Product Code: JWH
• UDI-Device Identifier: 10885862054272
• UDI-Public: 10885862054272
• 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: 2007
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2023

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: 02/15/2010
• Device Model Number: CC TIBIAL INSERT SZ 3, 15MM
• Device Catalogue Number: 208-23-15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2005
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown