STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_REJUVENATE STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number UNK_JR |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
Metal Related Pathology (4530)
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Event Date 02/07/2024 |
Event Type
Injury
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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 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 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 through the filing of a lawsuit that allegedly the patient¿s rejuvenate modular left hip implanted on or about (b)(6) 2011, was revised on (b)(6) 2024.It is further alleged that the plaintiff suffered injuries as a result of implantation and explantation of the device(s) at issue, device recall and excessive levels of chromium and cobalt in her blood.
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Search Alerts/Recalls
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