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Model Number 400-03-361 |
Device Problem
Failure to Align (2522)
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Patient Problem
Pain (1994)
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Event Date 11/22/2021 |
Event Type
Injury
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Event Description
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Revision surgery - patient was having pain post operation the previous surgery.Surgeon wanted to realign the cup to try and relieve pain, all components were well fixed.
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Manufacturer Narrative
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The reason for this revision surgery was reported as pain.The previous surgery and the surgery detailed in this event occurred 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 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 complaint was a revision surgery due to pain.There were no findings during this evaluation that indicate the reported devices were defective.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 also contribute to an event that are outside the control of djo surgical such as poor bone density, inadequate soft tissue support, patient activities or trauma.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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