STRYKER ORTHOPAEDICS-MAHWAH REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
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Catalog Number SPT-080000S |
Device Problem
Insufficient Information (3190)
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Patient Problems
Inflammation (1932); Reaction (2414)
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Event Date 06/11/2013 |
Event Type
Injury
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Manufacturer Narrative
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Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.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 5/12/2020: the plaintiff alleges that the right rejuvenate modular hip stem implanted on (b)(6) 2011 failed due to elevated levels of cobalt and chromium revealed in bloodwork, revision not yet scheduled.
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Search Alerts/Recalls
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