Catalog Number UNK-ASR |
Device Problem
Metal Shedding Debris (1804)
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Patient Problems
Pain (1994); No Code Available (3191)
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Event Date 12/02/2014 |
Event Type
Injury
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Event Description
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Litigation papers allege pain, shredding metal debris, and inhibition of the ability to walk.
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Event Description
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Litigation papers allege pain, shredding metal debris, and inhibition of the ability to walk.Update 2 dec 2014 - der rcvd.Updated dor and sales rep and surgeon information.Der states 'painful rt hip - revision of asr cup.
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, 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.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.
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Depuy still considers the investigation closed.
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Depuy still considers the investigation closed.
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Event Description
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(b)(4).
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Search Alerts/Recalls
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