Catalog Number UNK_JR |
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 01/16/2019 |
Event Type
Injury
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Manufacturer Narrative
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This event had been previously reported under asr submission for e2013004.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.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 was reported that the patient is asymptomatic.Additional information received from legal on 7/15/2020: plaintiff was implanted with a left rejuvenate modular hip stem on (b)(6) 2010.Its further alleged that the plaintiff had the left hip stem at issue explanted on (b)(6) 2018 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 revision due to 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 revision due to 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 was reported that the patient is asymptomatic.Additional information received from legal on 7/15/2020: plaintiff was implanted with a left rejuvenate modular hip stem on (b)(6) 2010.Its further alleged that the plaintiff had the left hip stem at issue explanted on (b)(6) 2018 due to elevated levels of cobalt and chromium in bloodwork.
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Search Alerts/Recalls
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