Catalog Number UNK HIP FEMORAL STEM |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
Inadequate Osseointegration (2646); No Code Available (3191)
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Event Date 01/01/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
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Event Description
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The literature article entitled, "primary total hip arthroplasty with fourth-generation ceramic-on-ceramic: analysis of complications in 939 consecutive cases followed for 2-10 years" written by martin a.Buttaro, md, gerardo zanotti, md, fernando m.Comba, md, and francisco piccaluga, md published by the journal of arthroplasty 32 (2017) 480e486 http://dx.Doi.Org/10.1016/j.Arth.2016.07.032 on 10 august 2016 was reviewed for mdr reportability.The article reports on 5 cases and 3 cases are identified with depuy products with adverse events which are captured individually in linked complaints.This complaint captures adverse events later discussed in the article besides the 5 individual cases.The article reports: "four patients presented a metaphyseal aseptic loosening of a corail (depuy international) stem at 2-3 years postoperative and were revised to a 200-mm cemented long stem non-depuy.
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Manufacturer Narrative
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Depuy synthese is submitting this report pursuant to the provision depuy synthese 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.Product complaint # : (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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