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.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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It was reported that the patient was having a left total hip.During the surgery, the surgeon broached to a 10 actis stem.The broach was very tight and rotationally stable.When the real implant was inserted, it sank all the way to the collar with no pressfit.The surgeon inserted the stem with his fingers and it seated fully and was loose.The surgeon went up one broach size and implanted the next size stem and got minimal pressfit, but the stem seemed to be stable and was retained.The pressfit of these stems is not enough to be solid.Doe: (b)(6) 2019.Left hip.
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