Model Number 322.02.932 |
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 08/27/2023 |
Event Type
Injury
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Event Description
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Trinity revision of ecima liner and metal head after approximately 3 weeks due to infection.
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Manufacturer Narrative
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(b)(4) initial report.Additional information including; operative notes, x-rays (pre and post revision), an update on the patient following the revision and did the patient follow the correct post-op protocol has been requested and if received, will be provided in a supplemental report upon completion of the investigation.The appropriate device details have been provided and the relevant device manufacturing records will be identified and reviewed.Please note: this report is filed with the fda due to an adverse event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.
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Manufacturer Narrative
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(b)(4).Final report - additional information including; operative notes, x-rays (pre and post revision), an update on the patient following the revision and did the patient follow the correct post-op protocol has been requested.No additional information were provided.The appropriate explanted device details were provided and the relevant device manufacturing and sterilization records have been identified and reviewed.Review of these records revealed no product non-conformity or deviation from process that would have caused or contributed to the reported infection.Based on the available information, no further investigation can be conducted and the root cause of the reported infection could not be identified.Infection is a known complication with any invasive surgery and this case is now considered closed.Please note: this report is filed with the fda due to an adverse event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.
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Search Alerts/Recalls
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