(b)(4).Multiple mdr reports were filed for this event.Please see reports: 0001825034-2017-06472.Concomitant medical products - unknown stem; unknown head; unknown cup; unknown liner.It has not been indicated the device will be returned for evaluation at this time.Legal documents summary notes 6 pseudotumors, 2 alval, and 4 with some symptoms that are unaccounted for within the 58 patient description.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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