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Model Number 322.04.740 |
Device Problems
Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
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Patient Problem
Joint Dislocation (2374)
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Event Date 08/24/2022 |
Event Type
Injury
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Event Description
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Trinity revision of the ecima liner after approximately 3 months due to dislocation.
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Manufacturer Narrative
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Per 5012 - fda initial report.Additional information, including x-rays, operative notes, patient medical history, patient age and activity level, if the patient experienced any trauma prior to the revision and an update following the revision, has been requested in order to progress with the investigation of this event, and if received, will be provided in a supplemental report upon completion of the investigation.The appropriate devices details have been provided and the relevant device manufacturing records will be identified and reviewed.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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Per 5012-fda final report: the appropriate devices details have been provided and the relevant device manufacturing records have been identified and reviewed.All parts associated with these records conformed to material and dimensional specifications at the time of manufacture.Additional information, including x-rays, operative notes, patient medical history, patient age and activity level, if the patient experienced any trauma prior to the revision and an update following the revision, has been requested.Unfortunately this information was not available, therefore the scope of the investigation is limited.The root cause of this event could not be determined based on the available information and thus this case is now considered closed, however, should any additional information be provided then this case may be re-opened for further investigation.Note: 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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Event Description
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Trinity revision of the ecima liner after approximately 3 months due to dislocation.
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Search Alerts/Recalls
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