STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN REJUVENATE MODULAR NECK; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number UNK_SHC |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
Foreign Body Reaction (1868)
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Event Date 02/26/2021 |
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 elevated levels of cobalt and chromium is considered to be under the scope of this recall.
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Event Description
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Kw 05-06-2021.Plaintiff was implanted with a left rejuvenate modular hip stem on (b)(6), 2011.Its further alleged that blood work revealed elevated levels of cobalt and chromium in bloodwork.The patients left hip was revised on (b)(6), 2020.
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Search Alerts/Recalls
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