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Model Number 497-28-000 |
Device Problems
Unstable (1667); Appropriate Term/Code Not Available (3191)
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Patient Problem
Failure of Implant (1924)
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Event Date 11/03/2020 |
Event Type
Injury
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Manufacturer Narrative
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Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
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Event Description
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Revision surgery - revision/ conversion of a bipolar hip to a total due to instability.
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Manufacturer Narrative
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Corrected data: see section d1., d2., d4., d10., & g4.Manufacturer narrative: the reason for this revision surgery was reported as instability.The actual length of in-vivo for the items listed is unknown as the original surgery date was not provided or could be established.The healthcare professional indicated there was significant adverse event to the patient.There was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The devices were disposed of at hospital and not made available to djo surgical for examination.This investigation is limited in scope as only partial information was provided to djo surgical.The revised items was not returned for examination and the lot numbers was not provided.To adequately investigate this event, the part and lot numbers are necessary.If this information is submitted at a future date, this investigation will be re-evaluated.Customer complaint history of the reported items showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to instability.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.The surgeon performed this revision to remedy the patient's condition.This complaint will be closed pending receipt of additional information.No further action is deemed necessary at this time.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
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Manufacturer Narrative
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Manufacturer narrative: the reason for this revision surgery was reported as instability.The actual length of in-vivo for the items listed is unknown as the original surgery date was not provided or could be established.The healthcare professional indicated there was significant adverse event to the patient.There was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The devices were disposed of at hospital and not made available to djo surgical for examination.This investigation is limited in scope as only partial information was provided to djo surgical.The revised items were not returned for examination and the lot numbers were not provided.To adequately investigate this event, lot numbers are necessary.Given the limited information, a search for an invoice (of the previous surgery) could not be conducted, therefore; the items removed could not be identified.If this information is submitted at a future date, this investigation will be re-evaluated.Customer complaint history of the reported items showed no present trends or on-going issues that are needing a review.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.The surgeon performed this revision to remedy the patient's condition.This complaint will be closed pending receipt of additional information.No further action is deemed necessary at this time.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
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Search Alerts/Recalls
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