STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN REJUVENATE MODULAR STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
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Catalog Number UNK_JR |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problems
Foreign Body Reaction (1868); Inflammation (1932)
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Event Date 08/19/2020 |
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.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.Not returned to the manufacturer.
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Event Description
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Information received from legal: plaintiff was implanted with a rejuvenate modular hip stem on his right hip on (b)(6) 2011, that failed and required revision on (b)(6) 2019 due to elevated levels of cobalt and chromium revealed in bloodwork.
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Event Description
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Information received from legal: plaintiff was implanted with a rejuvenate modular hip stem on his right hip on (b)(6) 2011, that failed and required revision on (b)(6) 2019 due to elevated levels of cobalt and chromium revealed in bloodwork.
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Manufacturer Narrative
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Correction: section g4- pma/510(k) or bla # is not available since the catalog number is unknown.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 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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