STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number UNK_JR |
Device Problem
Degraded (1153)
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Patient Problem
Metal Related Pathology (4530)
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Event Date 04/02/2024 |
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 metallosis.Intra-operatively, it was noted that the head had worn through the liner and the head was articulating against the shell.The shell, liner, and head were revised to competitor acetabular components with a stryker ceramic head.Rep provided explant pictures and confirmed that no further information will be released by the hospital or surgeon.
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Manufacturer Narrative
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An event regarding wear involving an unknown shell was reported.The event was not confirmed.Method & results: -product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs show a recently explanted shell with nothing remarkable to note.From the photographs provided there is no evidence of wear for the device.-clinician review: no medical records were provided for 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 metallosis.The reported device was not returned however photographs were provided for review.The photographs show a recently explanted shell with nothing remarkable to note.From the photographs provided there is no evidence of wear for the device.The exact cause of the event could not be determined because insufficient information was provided.Further information such as device identification details and return of the device 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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