STRYKER ORTHOPAEDICS-MAHWAH ABGII. MODULAR STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
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Catalog Number 4845-4-105 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Inflammation (1932); Reaction (2414)
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Event Date 06/23/2020 |
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.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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After the procedure with abgii modular, metallosis diagnosed in (b)(6) 2014 and therefore the need for further revision, explant and replacement of the prosthesis.
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Manufacturer Narrative
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Corrected data manufacturing date additional manufacturer narrative 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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Event Description
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After the procedure with abgii modular, metallosis diagnosed in (b)(6) 2014 and therefore the need for further revision, explant and replacement of the prosthesis.
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Search Alerts/Recalls
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