Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.Component code: appropriate term/code not available (g07002) used to capture no findings available.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 "revision of double-tapered, titanium, fully hydroxyapatite-coated femoral stems: ease of extraction and subsequent reconstruction" written graham r hastie, soheil g asle, anil gambhir and tim n board published by hip international on december 6, 2021 was reviewed.The articles purpose was to review the failures associated with the corail stem.104 patients involving corail ha stems were included within the study.There was no mention of acetabular cup or liner within the study.Adverse events: 46 revisions due to aseptic loosening.22 revisions due to infection.13 revision due to periprosthetic fractures.4 revisions due to pain.4 revisions due to instability.4 revisions due to armd.3 revisions due to leg length discrepancy.1 revision due to stem fracture.2 patients experienced sciatic nerve injuries.No mention of treatment associated.2 underwent dairs for infection.1 patient with superficial infection.No mention of treatment associated.2 patients dvts.No mention of treatment associated.Additional revisions unrelated to above adverse events that required etos patient 1 (66-years-old) with instability.Patient 2 (70-years-old) with aseptic loosening and pain.Patient 3 (62-years-old) with stem fracture.Patient 4 (78-years-old) with infection.Patient 5 (60-years-old) with infection.
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