Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.H6 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 asr hip arthroplasty: analysis of two hundred and ninety six recalled patients at seven years¿ written by giovanni benelli, merildo maritato, pierpaolo cerulli mariani, and francesco sasso was published in international orthopaedics on september 7, 2018 was reviewed.The aim of this study is to present an algorithm for the evaluation of both symptomatic and asymptomatic patients.296 hips (15 bilateral mom patients) were included within the study.51 had been implanted with asr resurfacing and 245 were implanted with asr tha with a corail femoral stem.Adverse events 100 hips underwent revision.Indications for revision included cup loosening (8), alval (51), cup mispositioning, taper corrosion was noted at revision, elevated levels of cobalt and/or chromium, and pain.-six of 296 hips had elevated levels of cobalt and/or chromium.No intervention noted.Cup mispositioned without intervention.
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