STRYKER ORTHOPAEDICS-MAHWAH ABGII MODULAR SHORT NECK; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
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Catalog Number 4845-4-410 |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problems
Foreign Body Reaction (1868); Metal Related Pathology (4530)
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Event Date 11/09/2023 |
Event Type
Injury
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Manufacturer Narrative
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Similar events have occurred for the product family.These events were determined to be associated with ra 2012-067.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 pain is considered to be under the scope of this recall.No further investigation is required.H3 other text : not returned to the manufacturer.
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Event Description
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The customer reported to ansm: "abg ii - stryker prosthesis design defect, causing granuloma, osteolysis and pain, leading to total prosthesis replacement (increased chroma and cobaltaemia) of the prosthesis (increased chroma and cobalt levels.)".
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Search Alerts/Recalls
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