STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_SECUR-FIT ADVANCED STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number UNK_JR |
Device Problem
Loss of Osseointegration (2408)
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Patient Problem
Insufficient Information (4580)
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Event Date 04/07/2023 |
Event Type
Injury
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Manufacturer Narrative
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Reported event: an event regarding loosening of an unknown securfit stem was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to stem loosening, the shell was also revised due to malposition.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
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Event Description
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It was reported that the patient's right hip was revised due to stem loosening.The surgeon also decided to revise the shell to change its positioning.The stem, head, liner, and shell were revised.Rep confirmed that there were no allegations against the revised head and liner.Rep also confirmed that aside from some additional patient details, no further information will be released by the hospital or surgeon.
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