Catalog Number 157001135 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).Depuy synthes has been informed that the lot number is not available.
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Event Description
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New etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint - litigation papers allege: patient was implanted with a depuy asr hip on his left side on or about (b)(6) 2010.He later suffered pain and elevated levels of cobalt and chromium ions in his blood.He has not yet scheduled an explantation of the asr hip.Update: plaintiff fact sheet received with part/lot information.No new information was received that would change the outcome of the investigation.Update rec'd 12/10/2015 - patient was revised for pain and high ion levels.The lot has been provided for the head, and the stem and sleeve have been added for the high ion levels.
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Manufacturer Narrative
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(b)(4).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.Ref.Wwcapa (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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Manufacturer Narrative
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This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(b)(4).
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Event Description
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Update 2/17/16- medical records received.Medical records reviewed for mdr reportability.Revision surgical note reported adverse tissue reaction with metal staining of tissues.Lot updated on stem.The complaint was updated on: mar 4, 2016.
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Manufacturer Narrative
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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.Ref.Wwcapa (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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