Vigilance Form

Section 1: Submitters details

Section 2: Complaint information

Event details (please check all that apply)

Date of implantation

Date of explantation

Section 3: Device information

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Section 4: Associated device information

Product 1

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Product 2

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Product 3

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Product 4

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Product 5

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Section 5: Additional information

For revisions resulting from infection or metallosis, please supply and attach all or any of the following; pathology report, surgical report or feedback, histology report, blood test results (e.g. CoCr levels)

For all other revisions, please supply and attach any or all of the following; x-rays (pre and post op), bone scans, CT scans, MRI images, surgical report or feedback.

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