Model Number 322.03.636 |
Device Problems
Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/25/2019 |
Event Type
Injury
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Manufacturer Narrative
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Per 2622 initial report.In order to progress with the investigation of this event, operative notes, patient details and an update on the patient following revision has been requested, however, this information is not available and thus the investigation of this event is limited.A post primary x-ray has been provided and will be reviewed at corin.It has been confirmed that the explants will not be returned for examination.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.
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Event Description
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Trinity revision of the cup, head and liner after approximately 4 months due to dislocation.
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Manufacturer Narrative
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Per (b)(4) final report: additional information including operative notes, patient details, an update on the patient following the revision and return of the explanted devices was requested in order to progress with the investigation of this event, however, this information could not be provided and thus the investigation was very limited.A post primary x-ray was provided and reviewed at corin.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All finished parts associated with these records conformed to material and dimensional specification at the time of manufacture.Based on the above, no further investigation can be conducted and the root cause of the reported dislocation could not be determined 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.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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Event Description
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Trinity revision of the head, liner and cup after approximately 4 months due to dislocation.
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Search Alerts/Recalls
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