Catalog Number 402283 |
Device Problems
Loose or Intermittent Connection (1371); Unstable (1667); Appropriate Term/Code Not Available (3191); Noise, Audible (3273)
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Patient Problems
Pain (1994); Swelling (2091)
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Event Date 02/05/2018 |
Event Type
Injury
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Manufacturer Narrative
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The reason for this revision surgery was reported as pain, instability, clicking and swelling.The actual length of in-vivo for the item listed is unknown as the event date could not be determined.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) show that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There were 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 pain, instability, clicking and swelling.There were no findings during this evaluation that indicate that the reported device was 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 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.
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Event Description
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Revision surgery - it was reported that the patient was revised due to pain, knee wobbly (instability), clicking, swelling, and falling over 20 times.Subsequently, an xrays/scans allegedly revealed the cement came loose on both parts.In additional, the patient has had two procedures due to the screw becoming lost.Attempts have been made and no further information has been provided.
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Search Alerts/Recalls
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