Clinical adverse event received for right groin pain, and right leg swelling with numbness and tingling.Event is not serious and is considered moderate.Event is definitely not related to device and is possibly related to procedure.Date of implantation: (b)(6) 2020.Date of event (onset): (b)(6) 2020, (right hip).Treatment: diagnostic intervention (unspecified).
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.
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