STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_66F RAS SHELL; 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 Problems
Inadequate Osseointegration (2646); Fibrosis (3167)
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Event Date 01/05/2024 |
Event Type
Injury
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Manufacturer Narrative
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Reported event: an event regarding loosening involving an unknown shell 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: insufficient information was provided to support a medical review.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 loosening of the shell and fibrous ingrowth.Intra-operatively, screws were noted to be broken.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.H3 other text : device not returned to the manufacturer.
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Event Description
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It was reported that the patient's right hip was revised due to loosening of the shell and fibrous ingrowth.Intra-operatively, screws were noted to be broken.The shell, screws, liner, and head were revised.Rep confirmed there are no allegations against the revised liner and head, and that no further information will be released by the hospital or surgeon.
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