STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/54; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
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Catalog Number 1236-2-854 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Unspecified Infection (1930); Injury (2348); Reaction (2414)
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Event Date 12/26/2018 |
Event Type
Injury
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Manufacturer Narrative
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Reported event: an event regarding infection involving an adm liner 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 recently explanted devices; an mdm liner and adm liner and a ceramic head (competitor device).There is blood and what appears to be biological matter on the explanted components.The ceramic head remains in the adm liner.There is nothing else remarkable to report.Clinician review: no medical records were received for review with a clinical consultant.Product history review: indicate all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot or sterile lot referenced.Conclusions: the event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.Further information such as device return, pre and post operative x-rays, operative reports, pathology reports including the strain of infection identified as well as patient history and follow up notes are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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Event Description
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As reported: [surgeon] removed mdm liner and insert from patient.Replaced with a stryker trident x3 10° poly insert".Spoke to rep.Patient was revised due to suspected infection and suspected metallosis (infection and metallosis suspicions reported by surgeon, unknown if clinically confirmed/ identified).Rep provided explant pictures showing the mdm/ adm liner construct and competitor ceramic head explanted (rep confirmed the head was a competitor head).
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Search Alerts/Recalls
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