Catalog Number SPT-080000S |
Device Problems
Device-Device Incompatibility (2919); Insufficient Information (3190)
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Patient Problems
Inflammation (1932); Injury (2348); Reaction (2414)
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Event Date 03/22/2016 |
Event Type
Injury
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Manufacturer Narrative
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Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.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 revision, trunnionosis and corrosion 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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Information received from broadspire: it was reported that the patient is asymptomatic.Update 28/july/2020 (b)(6): it was reported that the patient's left hip was revised due to trunnionosis at the head/ neck junction and corrosion at the head/ neck and stem/ neck junctions.Patient was revised to a restoration ha stem and ceramic head.Rep confirmed that the liner and shell were not revised.No further information will be released by the hospital or surgeon.
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Event Description
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Information received from broadspire: it was reported that the patient is asymptomatic.Update 28/july/2020 wg: it was reported that the patient's left hip was revised due to trunnionosis at the head/ neck junction and corrosion at the head/ neck and stem/ neck junctions.Patient was revised to a restoration ha stem and ceramic head.Rep confirmed that the liner and shell were not revised.No further information will be released by the hospital or surgeon.
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Manufacturer Narrative
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Reported event: an event regarding corrosion 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.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-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 corrosion 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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