Catalog Number UNK HIP FEMORAL HEAD |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Pain (1994); Physical Asymmetry (4573)
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Event Date 01/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.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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Event Description
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Article entitled ¿exeter vs summit stems in total hip arthroplasty at 5 year follow up.¿ written by c.O¿sullivan, g.Sheridan, l.Vernon, k.Linehan, n.Lynch, r.Gul, s.Guerin, and j.Harty published in irish medical journal in 2018 was reviewed.This retrospective cohort study seeks to compare the clinical outcomes of the exeter cemented stem and the summit cementless stem at a minimum of five years.817 patients were involved in the study.Of those 394 patients were implanted with a cementless summit stem.Of those 394 patients, 392 were implanted with a pinnacle cup.Adverse events for summit within 5 years: 1 patient was revised for pain.4 patients were revised for periprosthetic fractures.1 patient was revised for infection.2 patients were revised for leg length discrepancy.
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Manufacturer Narrative
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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.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
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Search Alerts/Recalls
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