Catalog Number UNK-ASR |
Device Problems
Metal Shedding Debris (1804); Appropriate Term/Code Not Available (3191)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994)
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Event Date 07/23/2015 |
Event Type
Injury
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Manufacturer Narrative
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This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.(b)(4).Depuy considers the investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.
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Event Description
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Litigation documents received.Litigation alleges that patient underwent a revision to address cup loosening, pain, metallosis, shedding of metal debris and elevated metal ions.
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Manufacturer Narrative
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Depuy considers the investigation closed.Should additional information be received the investigation will be reopened.
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Event Description
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Update 11/7/2016 medical records received.After review of the medical records for mdr reportability, there is no new additional information that would affect the existing investigation.
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Search Alerts/Recalls
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