STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_ABG II MODULAR PROTHESIS NECK; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
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Catalog Number UNK_SHC |
Device Problem
Material Erosion (1214)
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Patient Problem
Foreign Body Reaction (1868)
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Event Date 11/26/2008 |
Event Type
Injury
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Manufacturer Narrative
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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 tissue intolerance reaction of immuno-allergic origins considered to be under the scope of this recall.No further investigation is required.
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Event Description
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It was reported, "upon review of medical documentation received, the clinician's assessment indicates that the abgii modular devices, have a direct and certain relationship of cause and effect to this patient's experience, namely the tissue intolerance reaction of immuno-allergic origin, which began on (b)(6) 2009, and ended on (b)(6) 2018 (consolidated)." this report is for the abg ii modular prothesis neck.
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Search Alerts/Recalls
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