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Model Number 412-02-045 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Unspecified Infection (1930)
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Event Date 05/28/2021 |
Event Type
Injury
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Manufacturer Narrative
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The reason for this revision surgery was reported as an infection.The previous surgery and the surgery detailed in this event occurred 8.7 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 hospital and not made available to djo surgical for examination.A review of the device history records (dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material reports (ncmr) associated with the products that may have contributed to the reported event.The devices were verified to have gone through an acceptable sterilization process and were within its expiration date at the time of the previous surgery.Customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review.The root cause of this compliant was a revision surgery due to an infection.There were no findings during this evaluation that indicate that the reported devices were the source or had a direct connection with the patient's infection.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 possible infection or inhibited the patient's immune system.There are multiple factors that may contribute to an infection that are outside the control of djo surgical.With the limited information provided about the patient and the devices removed during the revision surgery, it is impossible to determine the source of the infection.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 as soon as it becomes available.
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Event Description
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Revision surgery - late infection of previous bipolar hip surgery.Patient was taken to surgery and femoral head and bipolar component were removed, irrigation and debridement performed and same size components were opened and implanted.
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Search Alerts/Recalls
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