STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number 502-11-52E |
Device Problems
Fracture (1260); Malposition of Device (2616)
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Patient Problems
Inflammation (1932); Injury (2348)
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Event Date 04/27/2020 |
Event Type
Injury
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Manufacturer Narrative
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If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
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Event Description
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It was reported that the patient's right hip was revised due to dissociation of the head from the stem.Intra-operatively, the following were noted: trunnion wear, metallosis in the joint, the trunnion penetrated the liner and scratched up the inside of the shell.Due to the shell's version (reported as almost neutral), the patient's entire construct including 2 screws were revised.
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Event Description
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It was reported that the patient's right hip was revised due to dissociation of the head from the stem.Intra-operatively, the following were noted: trunnion wear, metallosis in the joint, the trunnion penetrated the liner and scratched up the inside of the shell.Due to the shell's version (reported as almost neutral), the patient's entire construct including 2 screws were revised.
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Manufacturer Narrative
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Reported event: an event regarding malposition involving trident shell was reported.The event was not confirmed method & results: -device evaluation and results:visual inspection: visual inspection was performed as part of the material analysis report (mar), dated (b)(6) 2020.This inspection indicated biological material was observed on the porous surface of the shell.Damage consistent with cyclic contact against the stem was observed on the inner surface of the shell.Dimensional inspection: not performed as the dimensional aspects are not in question.Functional inspection: not performed as the functional aspects are not in question.Material analysis a material analysis has been performed.The report concluded: wear damage consistent with the loss of taper lock was observed on the stem trunnion and head taper.Biological material was observed on the porous coating of the shell and stem.Xrf showed that the stem, head, and shell components were consistent with the material call out on their respective drawings.Adhered material on the head taper was consistent with material transfer from the stem and an oxide.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined for the devices with catalog numbers provided.-clinician review:-a review of the provided medical records and x-rays by a clinical consultant was rejected indicating " right hip was revised due to disassociation of the head from the stem trunnion wear, metallosis entire construct revised "undated, unlabelled x-ray ap right hip demonstrating uncemented right tha, 2 screws in acetabular component, head disassociated from trunnion and remains in the acetabular component.Trunnion dislocated with erosion of the superior surface noted.No clinical or pmh, no op reports, no dated serial imaging studies, no examination of explanted components.The x-ray confirms the event description, but creating a medical report based upon a single x-ray is not possible." -device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusion: it was reported that the patient's right hip was revised due to dissociation of the head from the stem.The event was not confirmed.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
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