On (b)(6) 2013, the patient underwent a primary total right hip replacement.The primary operative notes not available at the time of this review.On (b)(6) 2017, the patient underwent a revision of the head and liner due to pain, metallosis, liner/cup disassociation, and poly liner wear.On (b)(6) 2017, the patient underwent a total hip revision due to pain, squeaking, poly/liner disassociation, poly liner fracture, and metallosis.The surgeon reported no complications.
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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.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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