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 7236-2-854 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 02/22/2023 |
Event Type
Injury
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Event Description
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Patient had a right tha on (b)(6) 2023.Patient developed periprosthetic joint infection and was revised on (b)(6) 2023.All components were exchanged.
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Manufacturer Narrative
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An event regarding infection 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 or sterile lot referenced.Conclusions: it was reported that the patient was revised due to infection.All stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance with applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports 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.The following devices were also listed in this report: cat# 702-04-60g; tridentii tritanium cluster60g; lot# 94245801a.Cat# 626-00-48g; modular dual mobility insert; lot# 92295604.Cat# 6570-0-228; delta v-40 ceramic head 28/+4; lot# 94585903.Cat# 7000-6610; high insignia collared hip stem; lot# 95306703.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
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Search Alerts/Recalls
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