STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN REJUVENATE MODULAR NECK; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
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Catalog Number UNK_SHC |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problems
Foreign Body Reaction (1868); Metal Related Pathology (4530)
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Event Date 03/25/2022 |
Event Type
Injury
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Manufacturer Narrative
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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 cobalt and chrome is considered to be under the scope of this recall.No further investigation is required.This event was reported through an attorney, as a result of a legal claim.Due to the ongoing litigation, no additional information is available at this time.If additional information is received it will be reported on a supplemental report.Device not returned.
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Event Description
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Plaintiff was implanted with a right rejuvenate modular hip stem on (b)(6), 2011.It¿s further alleged that blood work revealed elevated levels of cobalt and chromium.The patient¿s right hip was revised on (b)(6), 2017.
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Manufacturer Narrative
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Reported event: an event regarding abnormal ions 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 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 abnormal ions 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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Plaintiff was implanted with a right rejuvenate modular hip stem on (b)(6) 2011.It¿s further alleged that blood work revealed elevated levels of cobalt and chromium.The patient¿s right hip was revised on (b)(6) 2017.
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Search Alerts/Recalls
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