We have been informed by (b)(6) that this patient is deceased.Patient was bilateral.This com is for the left hip.Please see (b)(4) for right hip.Patient had asr resurfacing components implanted on (b)(6) 2008 by (b)(6).Implant hospital is unknown.They were not revised.Patient name: (b)(6); patient sex: m; patient dob: (b)(6).(b)(6) were notified of death on (b)(6) 2013.We do not know the date of death.Please see table of information rec'd from, (b)(6).We have also rec'd the product stickers for both hip sides.09 dec 2014 ¿ no further information is available to determine if this patient was revised.(b)(6) have confirmed that there is no allegation of a link between the asr implants and the death of the patient.Should further information become available, the complaint will be re-opened and evaluated for investigation.
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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.No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number.The correction/removal reporting number listed applies to the corresponding product code sold domestically.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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