Product complaint #: (b)(4).Investigation summary: no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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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Staff opened a sz 3 sigma femoral component - the component was removed from the sterile packaging and had a white contaminant on the polished edge of the prosthesis was surgery delayed due to the reported event? yes.If yes, number of minutes: 10.Action taken when event occurred? implant removed and replacement sourced.Was procedure successfully completed? yes.Were fragments generated? no.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: no.
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