MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; LOGIC TIBIA PS MOD INSRT SZ 4 15MM

Model Number	02-012-35-4015
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, approximately 9.91 years since initial implant, this female patient with bmi 32.1 underwent a right side tka and was implanted with an exactech uhmwpe insert, serial # (b)(4).On (b)(6) 2020, the patient underwent revision due to a periprosthetic fracture.No additional information is available or forthcoming.
Additional Manufacturer Narrative
Section h10: (h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design, manufacturing, or patient related issues.The cause of the fracture and subsequent revision cannot be conclusively determined; however, it is most likely is related to the patient¿s underlying condition.

• Brand Name: OPTETRAK
• Common Device Name: LOGIC TIBIA PS MOD INSRT SZ 4 15MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 13453243
• Report Number: 1038671-2022-00175
• Device Sequence Number: 4627850
• Product Code: JWH
• UDI-Device Identifier: 10885862001917
• UDI-Public: 10885862001917
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2022

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: 01/04/2014
• Device Model Number: 02-012-35-4015
• Device Catalogue Number: 02-012-35-4015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2022
• Supplement Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2009
• 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; Hospitalization
• Patient Sex: Female