Model Number 322.03.636 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problem
Pain (1994)
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Event Date 09/06/2022 |
Event Type
Injury
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Manufacturer Narrative
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Per -5075 initial report additional information including post primary and pre revision x-rays, operative notes, when the pain started, whether the patient followed correct post-op protocol, whether the patient experienced any slips / falls or other trauma post primary surgery 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, 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 ecima liner and ceramic head after approximately 10 months due to pain.
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Manufacturer Narrative
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Per -5075 final report additional information including post primary and pre revision x-rays, operative notes, when the pain started, whether the patient followed correct post-op protocol, whether the patient experienced any slips / falls or other trauma post primary surgery and an update on the patient post revision was requested in order to progress with the investigation of this event, however, not all information could be received and thus the scope of the investigation was limited.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.It was found that all finished parts associated with these records conformed to material and dimensional specification at the time of manufacture.Based on the available information, no further investigation can be conducted and the root cause of the reported pain 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, 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 ecima liner and ceramic head after approximately 10 months due to pain.
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Search Alerts/Recalls
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