STRYKER ORTHOPAEDICS-MAHWAH REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
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Catalog Number SPT-080000S |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problems
Foreign Body Reaction (1868); Inflammation (1932); Metal Related Pathology (4530)
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Event Date 11/10/2020 |
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 corrosion 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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It was reported that following a revision of rejuvenate femoral stem for fibrous, pseudo-tumor it was discovered that the patient exhibited evidence of metallosis and abductor deficiencies.
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Event Description
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It was reported that following a revision of rejuvenate femoral stem for fibrous, pseudo-tumor it was discovered that the patient exhibited evidence of metallosis and abductor deficiencies.
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Manufacturer Narrative
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Correction: d4 lot updated from minrdn to mjnrdn.Reported event: an event regarding altr and metallosis involving a rejuvenate modular device was reported.The event was not confirmed.Method & results: device evaluation and results:visual inspection: the device was not returned however photographs were provided for review.The image shows significant amount of blood on the device there is evidence of bone attached to the device.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.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.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: 4 undated, unlabelled color photos of explanted intact rejuvenate stem and attached modular neck with some boney ongrowth proximal stem with manufacturer's marking on stem visible - no gross pathology noted.Undated x-ray: ap left hip with uncemented, modular stem tha, reduced, nominal position with lateral femoral cortex defects and marked periarticular radio- dense particulate debris.No clinical or pmh, no patient demographics, no operative reports, no dated serial imaging studies.No lab or surgical pathology reports, no examination of explanted components.Based upon the information available for review, neither confirmation of the event description nor preparation of a medical report is possible for this case.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 and metallosis is considered not to be under the scope of this recall.No further investigation is required.
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Search Alerts/Recalls
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