Model Number E321.228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Joint Dislocation (2374)
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Event Date 07/15/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4) initial report.Additional information including; x-rays (primary and revision), operative notes, what was the patient doing at the time of the dislocation, did the patient follow correct post-op protocol and an update on the patient post revision has been requested 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 dual mobility / taperfit revision of the stem, cement restrictor, ecima insert and cocr modular head after 2 days due to dislocation.
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Manufacturer Narrative
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Case(b)(4).Final report additional information, including post primary and pre revision x-rays, operative notes (primary and revision), 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 were provided and the relevant device manufacturing records have been identified and reviewed.Review of these records revealed no product non-conformity or deviation from process that would have caused or contributed to the reported event.Based on the available information, 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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Search Alerts/Recalls
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