Catalog Number NLS-300000B |
Device Problems
Device-Device Incompatibility (2919); Insufficient Information (3190)
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Patient Problems
Inflammation (1932); Injury (2348); Reaction (2414)
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Event Date 05/03/2013 |
Event Type
Injury
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Manufacturer Narrative
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Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There has been another event for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.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 revealed in bloodwork is considered to be under the scope of this recall.No further investigation is required.Device not returned.
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Event Description
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It was reported that the patient is asymptomatic.Additional information received from legal on 7/22/2020: plaintiff was implanted with a rejuvenate modular hip stem on his left hip on or about (b)(6) 2011.It is further alleged that the plaintiff had the left hip stem at issue explanted on (b)(6) 2019 due to elevated levels of cobalt an chromium revealed in bloodwork.
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Manufacturer Narrative
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An event regarding elevated metal ions 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 found the devices in the reported lot were accepted into final stock with no reported discrepancies.-complaint history review: the complaint databases show there have been other events for the reported lot.Similar events have occurred for the catalog number and 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 elevated metal ions 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 was reported that the patient is asymptomatic.Additional information received from legal on 7/22/2020: plaintiff was implanted with a rejuvenate modular hip stem on his left hip on or about (b)(6) 2011.It is further alleged that the plaintiff had the left hip stem at issue explanted on (b)(6) 2019 due to elevated levels of cobalt an chromium revealed in bloodwork.
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Search Alerts/Recalls
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