Model Number 391-09-706 |
Device Problem
Unstable (1667)
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Patient Problem
No Code Available (3191)
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Event Date 09/15/2015 |
Event Type
Injury
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Event Description
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Revision surgery - due to instability.This is a study subject participating in the (b)(6) study run by (b)(6).The femoral component, baseplate and insert were all removed.The investigator for the study considered this to be device related.
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Manufacturer Narrative
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This mdr is being reported after learning about a potential device related event following a review of clinical study records.The internal standard operating procedure (sop) for complaint reporting has been updated to reflect a requirement for all clinical study events to be handled in the same manner as all product complaints.
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Manufacturer Narrative
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The reason for this revision surgery was due to left knee instability.The previous surgery and the revision detailed in this investigation occurred 1.8 years apart.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.There are no reported pre-existing patient health conditions.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 the hospital and not made available to djo surgical for examination.A review of the implant device history records (dhrs) show that the reported component used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the instability.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The device was verified to have gone through an acceptable sterilization process and was within it's expiration date at the time of use during the previous surgery.The root cause of this complaint was a revision surgery due to left knee instability.There were no findings during this investigation that indicate that the reported device was defective.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.
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Manufacturer Narrative
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Corrected data: added life threatening and disability events.Added concomitant part.Manufacturer narrative: this mdr is being reported after learning about a potential device related event following a review of clinical study records.The internal standard operating procedure for complaint reporting has been updated to reflect a requirement for all clinical study events to be handled in the same manner as all product complaints.The reason for this revision surgery was due to left knee instability.The previous surgery and the revision detailed in this investigation occurred 1.8 years apart.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.There are no reported pre-existing patient health conditions.The healthcare professional indicated there was a life threatening and disability event.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 the hospital and not made available to djo surgical for examination.A review of the implant device history records (dhrs) show that the reported component used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the instability.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The device was verified to have gone through an acceptable sterilization process and was within it's expiration date at the time of use during the previous surgery.The root cause of this complaint was a revision surgery due to left knee instability.There were no findings during this investigation that indicate that the reported device was defective.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.
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Search Alerts/Recalls
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