Catalog Number UNK HIP FEMORAL AUGMENT |
Device Problem
Biocompatibility (2886)
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Patient Problems
Death (1802); Renal Failure (2041); Obstruction/Occlusion (2422); Test Result (2695)
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Event Date 01/17/2014 |
Event Type
Death
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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)(6).(b)(4).
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Event Description
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The patient was implanted with an unknown model of proxima device on (b)(6) 2007.The patient was told that he had to be revised because (literally) the devices implanted were toxic.Also, in the report the lawyer reported that likewise asr case, the cr-co resulted in the patient blood as per blood test performed on (b)(6) 2012.On 17 jan 2014 (b)(4) have confirmed the product is an asr product.On 13 feb 2014 - response received from both kennedy & crawford that no further information is available at this point.Close the com until further information is available.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: revision of the device has been reported and there was no allegation that the device was a contributor to this event.No explanted devices have been received in respect of this patient for analysis.If further information is received indicating that the device was a contributor or there is an alleged deficiency of the device then this event will be re-opened for evaluation.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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