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
Pain (1994); Metal Related Pathology (4530)
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Event Date 12/16/2023 |
Event Type
Injury
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Manufacturer Narrative
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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.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: "date of implantation : (b)(6) 2010.Date of explantation : (b)(6) 2023"."incident information : date of occurrence: (b)(6) 2023.Incident description: acute loosening of the trident acetabulum on abg ii fitted 13 years ago.Observation of metallosis, a pretetrochanteric pseudotumour and a muscular lesion.As well as a significant muscular lesion of the gluteus medius.Patient information: patient's current condition: change of thp for a complete future + metaphyseal cerclage.Post-operative course simple, pain relieved by usual analgesics, satisfactory control x-ray, clean, non-inflammatory scar.Inflammatory.The patient was able to get up and walk around with the help of the physiotherapists without any difficulty.Actions taken in the healthcare establishment to manage the patient: ansm declaration + preservation of the dm + information from the manufacturer/laboratory".
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Manufacturer Narrative
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An event regarding altr 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 altr 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 customer reported: "date of implantation : (b)(6) 2010.Date of explantation : (b)(6) 2023"."incident information : date of occurrence: 16/12/2023.Incident description: acute loosening of the trident acetabulum on abg ii fitted 13 years ago.Observation of metallosis, a pretetrochanteric pseudotumour and a muscular lesion.As well as a significant muscular lesion of the gluteus medius.Patient information: patient's current condition: change of thp for a complete future + metaphyseal cerclage.Post-operative course simple, pain relieved by usual analgesics, satisfactory control x-ray, clean, non-inflammatory scar.Inflammatory.The patient was able to get up and walk around with the help of the physiotherapists without any difficulty.Actions taken in the healthcare establishment to manage the patient: ansm declaration + preservation of the dm + information from the manufacturer/laboratory".
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