Catalog Number P11V0612 |
Device Problem
Delivered as Unsterile Product (1421)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/05/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).G2-foreign- japan investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
|
|
Event Description
|
It was reported that during a total knee arthroplasty, the nurse noticed a foreign substance (fibre) within the implant packaging.Surgery was completed with another implant.This event is related to a malfunction that could potentially lead to a sterility issue.Due diligence is in progress for this complaint; to date, whatever additional information received has been included in this report.
|
|
Manufacturer Narrative
|
(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the product and pictures has been done.Item and lot numbers outer and inner matches the complaint.Seal has been broken on inner tyvek.Hair like substance is seen in photos attached.No other damage noticed.A review of the device manufacturing records confirmed no abnormalities or deviations.Device is used for treatment.Reported event did occur in an operating room or as part of a medical procedure, but review of the medical records has not been performed, as the event is not related to the medical procedure.With the available information, a definitive root cause could not be determined.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
|
No further event information available at the time of this report.
|
|
Search Alerts/Recalls
|