Catalog Number UNK_SHC |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problems
Inflammation (1932); Reaction (2414)
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Event Date 01/09/2013 |
Event Type
Injury
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.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.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 elevated levels of cobalt and chromium is considered to be under the scope of this recall.No further investigation is required.
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Event Description
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It is reported that: patient is asymptomatic.Additional information received from legal on 5/12/2020: the plaintiff alleges that the left rejuvenate modular hip stem implanted on (b)(6) 2012 failed due to elevated levels of cobalt and chromium revealed in bloodwork.Revision not yet scheduled.
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Manufacturer Narrative
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An event regarding abnormal ion level involving a 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 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 abnormal ion level is considered to be under the scope of this recall.No further investigation is required.
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Event Description
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It is reported that: patient is asymptomatic.Additional information received from legal on 5/12/2020: the plaintiff alleges that the left rejuvenate modular hip stem implanted on (b)(6) 2012 failed due to elevated levels of cobalt and chromium revealed in bloodwork.Revision not yet scheduled.
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Search Alerts/Recalls
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