MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	244-24-09
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Discomfort (2330); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Joint Laxity (4526)
Date of Event	03/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Correction/removal number: z-0019-2022.
Event or Problem Description
As reported by legal notification, the male patient had an initial right tka on (b)(6) 2009.The patient was revised on (b)(6) 2016 due to accelerated and preventable wear of the optetrak polyethylene tibial insert.No other patient information/medical history reported.
Additional Manufacturer Narrative
H6: corrected the following: health effect - clinical code, impact code, medical device code, component code, type of investigation, investigation findings, investigation conclusions.The reason the revision reported cannot be determined from the available information but may have been reported at this later time due to inclusion of one of the implanted devices in the packaging recall.However, the reported prosthesis wear/failure, instability and loosening could not be confirmed and potential contributions of user, or patient-related considerations to the event could not be assessed as no images or radiographs were provided, relevant clinical information was not provided, and the devices were not available for evaluation.

• Brand Name: OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16629957
• Report Number: 1038671-2023-00526
• Device Sequence Number: 14580760
• Product Code: JWH
• UDI-Device Identifier: 10885862064035
• UDI-Public: 10885862064035
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2016
• 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): 10/11/2024

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: 04/11/2012
• Device Model Number: 244-24-09
• Device Catalogue Number: 244-24-09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2007
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male