STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACCOLADE TMZF STEM SIZE 2.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number UNK_SHC |
Device Problem
Degraded (1153)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Metal Related Pathology (4530)
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Event Date 03/04/2024 |
Event Type
Injury
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Event Description
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It was reported that the patient's left hip was revised due to metal reaction and elevated ion levels.An accolade tmzf stem, lfit head, and poly liner were revised to a restoration modular stem construct with cable and sleeve set, ceramic head, adm/ mdm poly insert, and mdm metal liner.Rep confirmed that no further information will be released by the hospital or surgeon.
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Manufacturer Narrative
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Reported event: an event regarding allergy/reaction & abnormal ion levels involving an unknown accolade 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's left hip was revised due to metal reaction and elevated ion levels.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 primary 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.
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