Ad 31 jan & 23 feb 2018: medical records received.After review of medical records for the mdr reportability, patient was revised to address loosening of the hip prosthesis cupula with bone loss.Clinical notes reported of limping, and bony callus.Head will be reported since it was revised.There is no products or sticker sheets provided in the source document implanted on (b)(6) 2013.Doi: (b)(6) 2013 ; dor: (b)(6) 2014 (left hip).Pc-(b)(4) for first revision.Pc-(b)(4) for third revision.
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(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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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