Model Number N/A |
Device Problem
Difficult or Delayed Positioning (1157)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 01/18/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Foreign report source: (b)(6).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 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 00728.
|
|
Event Description
|
It was reported the surgeon had difficulty inserting the trilogy liner into the trilogy shell, but was finally able to seat the liner properly.Attempts have been made and additional information on the reported event is unavailable at this time.
|
|
Manufacturer Narrative
|
D4: (b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Root cause was 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 further event information is available at the time of this report.
|
|
Search Alerts/Recalls
|