STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 56MM OSTEOLOCK 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 Problem
Inadequate Osseointegration (2646)
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Event Date 03/07/2023 |
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: 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 aseptic shell loosening.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 aseptic shell loosening.The shell, 2 screws, liner, and head were revised to a multi-hole shell with 6 screws, mdm metal liner, adm/ mdm poly insert, and ceramic head with sleeve.
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