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

Model Number	PS CEMENTED FEMORAL SZ 2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/16/2010
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 united kingdom national joint registry (uknjr).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.
Event or Problem Description
As reported by united kingdom national joint registry (uknjr), a (b)(6) y/o, 160 cm, (b)(6) kg (bmi=32), female patient underwent primary total prosthetic replacement using cement of the right knee on (b)(6) 2009.The indication for the index procedure was osteoarthritis.On (b)(6) 2010, approximately 15 months post implantation, the patient underwent revision due to component dissociation; dislocation subluxation.Follow-ups for additional information cannot be performed for this complaint, information was submitted as complete by the united kingdom national joint registry (uknjr); 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.The patient has a high bmi which indicates that they are overweight, this can increase biomechanical stressors on natural and artificial joints.No additional patient medical history/information is provided.
Additional Manufacturer Narrative
Section h11: this event is a duplicate of 1038671-2020-00111.Please disregard.

• Brand Name: OPTETRAK
• Common Device Name: PS CEMENTED FEMORAL SZ 2
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9703645
• Report Number: 1038671-2020-00102
• Device Sequence Number: 3007483
• Product Code: JWH
• UDI-Device Identifier: 10885862047571
• UDI-Public: 10885862047571
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K933494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2010
• 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: 06/06/2012
• Device Model Number: PS CEMENTED FEMORAL SZ 2
• Device Catalogue Number: 204-01-02
• 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
• Patient Age: 53 YR
• Patient Weight: 81