This report is being amended to reflect changes in date received by mfr, type of reports, if follow-up, what type?, evaluation codes, and additional mfr narrative.No device or photos were received, therefore the condition of the device is unknown.Review of device history records identified no deviations or anomalies in the manufacturing process.This device is used for treatment.Review of complaint history for the part-lot combination of the reported device identified no additional complaints.It could not be confirmed if the device was used in an approved and compatible combination.Surgical notes were not provided.It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.Relevant medical history and adherence to rehabilitation protocol are unknown.Follow up was performed to confirm if surgical technique or the reported ineffectual templating contributed to the reported event, however no additional information was provided.A definitive root cause cannot be determined with the information provided.
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