STRYKER ORTHOPAEDICS-MAHWAH ABGII MODULAR SHORT NECK; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
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Catalog Number 4845-4-410 |
Device Problems
Device-Device Incompatibility (2919); Insufficient Information (3190)
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Patient Problems
Inflammation (1932); Pain (1994); Reaction (2414); Ambulation Difficulties (2544)
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Event Date 06/01/2013 |
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 three other events reported for the lot code.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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The patient's lawyer reports that on (b)(6) 2012 the patient was implanted with an abgii mod.But after about a year and a half she began to experience pain in the hip, groin and leg, and to be severely limited in movements.High levels of cobalt have been found, up to 10.68 in (b)(6) 2020.
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Manufacturer Narrative
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An event regarding rom and abnormal ion level involving a abgii modular device was reported.The event was confirmed for abnormal ion level but not for rom.Method & results: -device evaluation and results: device evaluation was not performed as it remained implanted.-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 while rom does not fall under recall.No further investigation is required.
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Event Description
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The patient's lawyer reports that on (b)(6) 2012 the patient was implanted with an abgii mod.But after about a year and a half she began to experience pain in the hip, groin and leg, and to be severely limited in movements.High levels of cobalt have been found, up to 10.68 in (b)(6) 2020.
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Search Alerts/Recalls
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