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Catalog Number UNK-ASR |
Device Problems
Metal Shedding Debris (1804); Noise, Audible (3273)
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Patient Problems
Pain (1994); Joint Swelling (2356); No Code Available (3191)
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Event Type
Injury
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Event Description
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Litigation papers allege including but not limited to grinding, metal flakes in and around the socket, fluid, pain, swelling, limited range of motion, adn elevated metal ions.
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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.
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Search Alerts/Recalls
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