It was reported that during summit stem impaction, the summit stem inserter became cold-welded to the stem due to a widened or "mushroomed" end of the inserter.When the surgeon pulled the inserter out, it pulled the stem out with it.No delay to surgery reported.No additional information.
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Product complaint # (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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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