Model Number 322.03.636 |
Device Problems
Device Dislodged or Dislocated (2923); Insufficient Information (3190)
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Patient Problems
Joint Dislocation (2374); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 09/23/2021 |
Event Type
Injury
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Event Description
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Trinity revision of the ecima liner and biolox delta ceramic head after approximately 1 year and 6 months due to dislocation.
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Manufacturer Narrative
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Per (b)(4) initial report.Additional information, including post primary and pre revision x-rays, operative notes, patient medical history, what the patient was doing at the time of the dislocation, whether the patient followed correct post-op protocol and an update on the patient post 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 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.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 and biolox delta ceramic head after approximately 1 year and 6 months due to dislocaton.
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Manufacturer Narrative
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Per -4854 final report.Additional information, including post primary and pre revision x-rays, operative notes, patient medical history, what the patient was doing at the time of the dislocation, whether the patient followed correct post-op protocol and an update on the patient post revision was requested in order to progress with the investigation of this event, however, this information could not be provided and thus the scope of the investigation was limited.The appropriate device details have been provided and the relevant device manufacturing records have been identified and reviewed.Review of these manufacturing records revealed no deviation from process or non-conformity of product that would have caused or contributed to the event.Based on the available information, no further investigation can be conducted and the root cause of the reported dislocation could not be determined.Therefore, 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.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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