MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; CEMENTED CR FEMORAL SZ 2

Model Number	200-01-02
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/23/2008
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.This submission represents 1 of 163 events identified via active surveillance activities utilizing data form the (b)(6) national joint registry ((b)(6)).Follow-ups for additional information cannot be performed for this complaint as the information was submitted as complete by the registry; there is no identification of facilities or surgeons.All available information about the event and/or patient has been provided and it is not possible to obtain any of the devices no information provided in the following section(s): race and test dates.
Event or Problem Description
As reported by (b)(6) national joint registry ((b)(6)), a (b)(6) y/o, male patient underwent primary total prosthetic replacement of the left knee on (b)(6) 2007.The indication for the index procedure was osteoarthritis.On (b)(6) 2008, approximately 13 months post implantation, the patient underwent revision due to detachment of device or device component (component dissociation).Follow-ups for additional information cannot be performed for this complaint, information was submitted as complete by the (b)(6) national joint registry ((b)(6)); there is no identification of facilities or surgeons.All available information about the event and/or patient has been provided.These devices are used for treatment not diagnosis.There has been no patient medical history/information provided; therefore, the patient risk/clinical factors cannot be assessed.
Additional Manufacturer Narrative
This event is a duplicate of 1038671-2020-00110.Please disregard.

• Brand Name: OPTETRAK
• Common Device Name: CEMENTED CR FEMORAL SZ 2
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9703634
• Report Number: 1038671-2020-00101
• Device Sequence Number: 11487517
• Product Code: JWH
• UDI-Device Identifier: 10885862039521
• UDI-Public: 10885862039521
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2020

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: 07/25/2012
• Device Model Number: 200-01-02
• Device Catalogue Number: 200-01-02
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 04/17/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention