Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.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.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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Article entitled ¿amino-hexaic acid and amino-methycyclic acid are used in total hip replacement random control studies¿ written by yang peng, ma jun, zeng junfeng, liu yuan, wu yuangang, and shen bin published in chinese journal of orthopedic surgery on (b)(6) 2022 was reviewed.The purpose of this study was to observe the effectiveness and safety of both drugs in tha by comparing the clinical effect of eaca and txa on reducing blood loss during the pre-operative phase of tha.99 patients were involved (49 patients had epsilon-aminocaproic acid (eaca) given and 50 had (tranexamic acid (txa) administered).All patients were implanted with a pinnacle cup, corail stem, and depuy femoral head and liner.Adverse events: there were three cases of intramuscular thrombosis in the eaca group and two cases in the txa group.No treatment noted.Neither group had acute thrombosis such as deep vein thrombosis and pulmonary embolism.One case of shallow honeycomb histitis occurred in the eaca group and the wound was healed and discharged after a change of medicine.One case of dislocation in the txa group.One case of vomiting occurred in txa group.No treatment noted.Two patients within the txa group received transfusions for blood loss.
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