Product complaint # (b)(4).Investigation summary: evaluation of the returned device was unable to identify foreign material present, however discoloration was noted.Depuy considers the investigation closed at this time.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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In depuy loaner department metal debris was seen on femur augments of the attune revision sets.All augments were affected but different degrees.The instrumentation was ready packed for shipment.The instrumentation was shipped a total of 8 times and was thoroughly cleaned 3 times with alcohol by an orthokit operator.In addition, there are noticeable rust marks, probably from the engraving.This was seen internally; no patient involvement, no surgery delay.
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