Catalog Number UNK_JR |
Device Problem
Insufficient Information (3190)
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Patient Problems
Death (1802); Injury (2348)
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Event Date 04/02/2018 |
Event Type
Death
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Manufacturer Narrative
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The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.The following devices were also listed in this report: unknown rejuvenate neck; cat#unknown; lot#unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
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Event Description
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Patient was implanted with a rejuvenate on (b)(6) 2011 and she was revised on (b)(6) 2017 where she went into cardiac arrest and passed away shortly afterwards.
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Manufacturer Narrative
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An event regarding revision involving an unknown rejuvenate modular device was reported.The event was confirmed.Method & results: device evaluation and results: device evaluation was not performed as no devices were received.Device history review: review of device history records could not be performed as the reported device was not properly identified.Complaint history review: a search of the complaint databases could not be performed as the reported device was not properly identified.Similar events have occurred for the rejuvenate modular product family.These events were determined to be associated with ra 2012-067.Conclusions: it was reported that patient was revised due to unknown reasons and shortly afterwards she went into cardiac arrest and passed away.Voluntary recall ra 2012-067 was initiated for abgii and rejuvenate modular stems and necks due to the potential risks associated with these devices.The reported revision is considered to be under the scope of this recall.No further investigation is required.Corrective action: ncr 106450 was initiated on (b)(6) 2012 because the occurrence rate for adverse local tissue reaction (altr) specified in the risk management files for the rejuvenate modular hip system was exceeded.Given the potential risk of fretting and corrosion with these devices, voluntary product recall ra 2012-067 was issued.
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Event Description
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Patient was implanted with a rejuvenate on (b)(6) 2011 and she was revised on (b)(6) 2017 where she went into cardiac arrest and passed away shortly afterwards.
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Search Alerts/Recalls
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