Catalog Number G426-0002 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Code Available (3191)
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Event Date 04/08/2016 |
Event Type
Injury
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Manufacturer Narrative
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The investigation is not complete.When the investigation is complete, this report will be updated.
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Event Description
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It was reported that there were inadequate labeling on implant indicating short stem or regular.On the short stem implant there is only a letter "s" next to the size number on the regular stem there is only a size number.This causes confusion to staff.There should be clearer labeling stating short stem or regular.Add'l info rec'd 4/22/2016: loan set ordered was short stem.Company set regular.One the box there is only a letter "s" to distinguish."in my opinion, it's not good enough.Short or regular should be written." patient was transferred to theatre recovery until a new implant was sent by courier.Waiting time 2.5 hours.This implant error was discovered during surgery although implants were checked prior to the case.There is no suitable sizes (ie.Short/regular stem) clearly written.
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Manufacturer Narrative
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This incident is considered closed.If at any time new or updated information becomes available, the incident will be re-opened and investigated.
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Search Alerts/Recalls
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