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Model Number 425-98-007 |
Device Problems
Crack (1135); Appropriate Term/Code Not Available (3191)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/28/2021 |
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 as soon as it becomes available.
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Event Description
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Revision surgery - as the surgeon was inserting the stem, he cracked the femur, so he had to explant the primary stem and replace it with the revision distal stem and proximal body.
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Manufacturer Narrative
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The reason for this revision surgery was reported as cracked femur.The previous surgery and the surgery detailed in this event occurred 2.3 months 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 device was disposed of at hospital and not made available to djo surgical for examination.A review of the device history record (dhr) shows that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There was no non-conforming material report (ncmr) associated with the product that may have contributed to the reported event.The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of the previous surgery.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 a cracked femur.There were no findings during this evaluation that indicate that the reported device was defective.No other 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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