No device or photos were received; therefore the condition of the device is unknown.The part and lot number of the device is unknown; therefore the device history records, complaint history could not be reviewed.The reported device is used for treatment.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.A definitive root cause cannot be determined with the information provided.
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