Catalog Number 110010242 |
Device Problem
Physical Resistance/Sticking (4012)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/08/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that during a procedure, the impactor stuck onto the shell.The products were explanted and separated by force.A new shell was used to complete the procedure.There was no harm or health consequences to the patient.Attempts have been made and no further information is available.
|
|
Manufacturer Narrative
|
Cmp-(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01487 d10: cat #: 110003450 / g7 str monoblock shell insrtr g2: australia the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
|
|
Manufacturer Narrative
|
(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The complaint is unable to be confirmed.Dhr was reviewed and not discrepancies related to the reported event were found.A definitive root cause is unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Event Description
|
No additional event "information" to report at this time.
|
|
Search Alerts/Recalls
|