Product complaint # (b)(4).Investigation summary: examination of the returned device confirms the reported event.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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It was reported that after surgery and instrument washing, two size 7 attune rp cr articulating surface trials were broken.One was cracked along the side and for the other, the connection lug broke off.Both instruments will be returned and no time was added to the case.
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