Catalog Number UNK_JR |
Device Problems
Degraded (1153); Device-Device Incompatibility (2919)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994); Metal Related Pathology (4530)
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Event Date 08/10/2023 |
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.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 event 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 through the filing of a lawsuit that allegedly the patient was implanted with a rejuvenate modular left hip on or about (b)(6), 2011.It is further alleged that the plaintiff developed pain, elevated cobalt in her blood and a pseudotumor.The patient was revised for altr on (b)(6), 2021.
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Event Description
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It was reported through the filing of a lawsuit that allegedly the patient was implanted with a rejuvenate modular left hip on or about (b)(6) 2011.It is further alleged that the plaintiff developed pain, elevated cobalt in her blood and a pseudotumor.The patient was revised for altr on (b)(6) 2021.
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Manufacturer Narrative
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Reported event: an event regarding altr 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 remained implanted.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 altr 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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