The patient was revised because of osteolysis, fractured femur (bone), and loosening of the stem at the cement/implant interface.Competitor cement originally used.(b)(4).The devices associated with this report were not returned.Review of the device history records and/or a complaint database search was not possible as the product and lot codes required were not provided.Requests for additional investigational inputs were made in accordance with wi-7915 appendix a.No additional information was obtained.The investigation could not verify or identify any product contribution to the reported event with the information provided, however, it has been reported that the depuy device was implanted with competitor manufactured cement.Based on the investigation the need for corrective action is not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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