Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
Event Type
malfunction
Manufacturer Narrative
This incident has been recorded under (b)(4).Upon completion of the investigation a final/supplemental report will be submitted.
Event Description
It was reported that during surgery, the device was skipping.No harm or delay have been indicated.No adverse event was reported as it relates to the event.Due diligence is complete, and no additional information is available.
Event Description
No additional information is available regarding the event.
Manufacturer Narrative
This complaint is recorded by zimmer biomet under: (b)(4).Review of the most recent repair record identified no repairs related to the reported event.A definitive root cause cannot be determined.The event cannot be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event Description
There is no additional event information available.
Manufacturer Narrative
Following sections were updated or corrected : b4, b5, d2, g1, g3, g6, h1, h2, h6, h10.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.