Catalog Number 4845-4-412 |
Device Problems
Device Appears to Trigger Rejection (1524); Device-Device Incompatibility (2919)
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Patient Problems
Foreign Body Reaction (1868); Inflammation (1932); Renal Impairment (4499)
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Event Date 01/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.If additional information is received, 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 chromium cobalt metal poisoning is considered to be under the scope of this recall.No further investigation is required.Device not returned.
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Event Description
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Discovery of acute renal failure.Total hip prosthetic implanted in 2011.Clinical surveillance.Dosage annual serum levels.Asymptomatic patient.Patient information: current status of the patient : kidney biopsy: chromium cobalt metal poisoning.Actions undertaken in the health care establishment for the care of the patient: removal of the prosthesis to be considered.
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Event Description
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Discovery of acute renal failure.Total hip prosthetic implanted in 2011.Clinical surveillance.Dosage annual serum levels.Asymptomatic patient.Patient information : current status of the patient : kidney biopsy: chromium cobalt metal poisoning.Actions undertaken in the health care establishment for the care of the patient: removal of the prosthesis to be considered.
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Manufacturer Narrative
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Reported event: an event regarding abnormal ion level involving a abgii 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 found the devices in the reported lot were accepted into final stock with no reported discrepancies. -complaint history review: the complaint databases show there have been other events for the reported lot.Similar events have occurred for the catalog number and 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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Search Alerts/Recalls
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