Catalog Number 114700 |
Device Problems
Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)
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Patient Problem
Insufficient Information (4580)
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Event Date 08/26/2020 |
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 - proximal loosening and subsequent perforation of anterior cortex.Ulna found to be well-fixed and stable, and thus preserved.
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Manufacturer Narrative
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The reason for this revision surgery was reported as loosening.The previous surgery and the surgery detailed in this event occurred 2.3 years apart.The healthcare professional indicated 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 the hospital and not made available to djo surgical for examination.The device history record (dhr) was not found among djo and available zimmer biomet records.Customer complaint history of the reported device 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 loosening.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the event.There are multiple factors that may contribute to an event that are outside the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.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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