Catalog Number 623-00-32C |
Device Problems
Device Operates Differently Than Expected (2913); No Apparent Adverse Event (3189)
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Patient Problems
Injury (2348); No Code Available (3191)
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Event Date 05/19/2015 |
Event Type
Injury
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Event Description
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Patients right hip was revised due to instability.Competitor cup and stryker head and liner were revised.Patient was initially implanted with stryker stem and head and zimmer liner and cup.Patient had a revision and a stryker liner was implanted.Reason for revision is unknown.".
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Manufacturer Narrative
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An evaluation of the device cannot be performed as the device was not returned due to hospital policy.Additional information has been requested and if received, will be provided in the supplemental report.Hospital policy.
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Manufacturer Narrative
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The reported event indicates the patient's trident liner was used in conjunction with a competitor shell which constitutes an off label combination of devices.The trident product family ifu indicates: "do not substitute another manufacturer¿s device for any of the howmedica osteonics trident system components because design, material, or tolerance differences may lead to premature device and/or functional failure.Components of the system have been specifically designed to work together.Any such use will negate the responsibility of howmedica osteonics corp.For the performance of the resulting mixed component implant." based on the provided information it has been determined that this event is associated with an off-label application.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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Patients right hip was revised due to instability.Competitor cup and stryker head and liner were revised.Patient was initially implanted with stryker stem and head and zimmer liner and cup.Patient had a revision and a stryker liner was implanted.Reason for revision is unknown.".
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Search Alerts/Recalls
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