Patient was revised to address instability and loosening of the tibial base component at the cement to implant interface.Cement manufacturer is depuy.The patient's flexion gap was greater than the extension gap.The attune size 5 ps femur was replaced by a larger attune size 6 revision crs femur to reduce the flexion gap.The patient's attune fb tibial base was found to be loose as well, so it too was replaced by an attune revision rp tibial base.The underside of the original tibial base was completely void of cement.The patient requested that he be given his explants following the completion of his surgery, since he had "paid for them." surgeon requested that the explant be cleaned by the hospital and given to him, so he could pass them on to his patient.Doi: (b)(6) 2015 dor: (b)(6) 2018 right knee.
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.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 will be filed as appropriate.
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