STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/52; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
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Model Number 7236-2-852 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Fall (1848); Joint Dislocation (2374)
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Event Date 05/01/2023 |
Event Type
Injury
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Event Description
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Right total hip revision/ dislocation of hip joint / mdm poly head disassociated from inner delta v/40 head / patient fell (per.Surgeon).Additional information: the sales rep noted that the surgeon explanted the screw and repositioned the shell.A new screw was used.
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Manufacturer Narrative
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An event regarding disassociation involving an adm liner 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: review of the device history records indicate 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 referenced.Conclusions: it was reported that the patient was revised due to disassociation of the adm liner from the ceramic head following a fall.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.Patient trauma likely contributed to the device failure as it was reported that the patient fell prior to revision.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 : not returned.
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