Catalog Number UNK_SHC |
Device Problems
Device-Device Incompatibility (2919); Insufficient Information (3190)
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Patient Problems
Foreign Body Reaction (1868); Inflammation (1932); Insufficient Information (4580)
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Event Date 09/23/2020 |
Event Type
Injury
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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.
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Event Description
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Information received from legal: plaintiff was implanted with a right rejuvenate modular hip stem on (b)(6) 2011.Its further alleged that the plaintiff had the right hip stem at issue explanted on (b)(6) 2020, due to elevated levels of cobalt and chromium in bloodwork.
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Event Description
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Information received from legal: plaintiff was implanted with a right rejuvenate modular hip stem on (b)(6) 2011.Its further alleged that the plaintiff had the right hip stem at issue explanted on (b)(6) 2020, due to elevated levels of cobalt and chromium in bloodwork.
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Manufacturer Narrative
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Reported event: 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 2012067 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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Search Alerts/Recalls
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