Udi: unavailable.Depuy synthes has been informed that the catalog number and lot number is not available.The asr platform was voluntarily recalled from the market in (b)(4), 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.Ref.Wwcapa 00780.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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Litigation papers received; patient alleges pain, shedding of metal debris, metallosis, tissue damage, decrease mobility and elevated metal ions.
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