Model Number 322.03.932 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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Patient Problems
Joint Dislocation (2374); Muscle/Tendon Damage (4532)
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Event Date 03/30/2021 |
Event Type
Injury
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Manufacturer Narrative
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Per -(b)(4) initial report.It was reported that the patient had a dislocation related to trauma, they fell over and ruptured the external rotators.Additional information, including post primary and pre revision x-rays, operative notes, patient age, patient activity level, patient medical history 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.
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Event Description
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Trinity revision of the ceramic head and ecima liner after approximately 3 years and 7 months due to dislocation.
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Event Description
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Trinity revision of the ceramic head and ecima liner after approximately 3 years and 7 months due to dislocation.
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Manufacturer Narrative
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Per -4197 final report.It was reported that the patient had a dislocation related to trauma, they fell over and ruptured the external rotators.Additional information, including post primary and pre revision x-rays, operative notes, patient age, patient activity level, patient medical history 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.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All 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 it has been concluded that the root cause of the reported dislocation was the patient falling and damaging soft tissues.Therefore, 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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