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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