Model Number 322.03.936 |
Device Problems
Malposition of Device (2616); Device Dislodged or Dislocated (2923)
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Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/16/2021 |
Event Type
Injury
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Manufacturer Narrative
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Per (b)(4) initial report.Additional information, including operative notes, patient details, whether the patient followed correct post-op protocol, what the patient was doing at the time of the dislocation and an update on the patient 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.It has been reported that the explanted devices are not available 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.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor contributed to this event.
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Event Description
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Trinity revision of the cup and ecima liner after 1 day due to dislocation.
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Manufacturer Narrative
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Per -3919 final report.Additional information, including operative notes, patient details, whether the patient followed correct post-op protocol, what the patient was doing at the time of the dislocation and an update on the patient following the revision was requested in order to progress with the investigation of this event, however, this information could not be provided and thus the scopr of the investigation was limited.It was reported that the explanted devices could not be returned for examination.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.A post primary and pre revision x-ray were provided and it was observed that the cup had moved position and looked to have been placed in cartilage rather than bone.Based on the available information it has been concluded that the dislocation was likely to have occurred as a result of a malpositioned cup during primary surgery 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 contributed to this event.
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Event Description
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Trinity revision of the cup and ecima liner after 1 day due to dislocation.
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Search Alerts/Recalls
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