Model Number N/A |
Device Problem
Separation Failure (2547)
|
Patient Problem
No Information (3190)
|
Event Date 11/12/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical product: item # 110003450, g7 str monoblock shell insrtr, lot # 299000.The event occurred in (b)(6).Multiple reports have been submitted for this event.Please see associated reports: 0001825034-2018-10996.
|
|
Event Description
|
It was reported that during a hip surgery, the cup inserter would not disengage from the cup.When attempting to remove the cup inserter, the cup moved, and was therefore removed.An alternative cup was implanted.Attempts have been made, and no further information has been provided.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.Udi - (b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual inspection confirmed the shell is seized to the inserter.The rim is dinged and a small amount of debris remains affixed to the porous coating.No other notable forms of damage were observed.Device history record was reviewed and no discrepancies relevant to the reported event 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.
|
|
Search Alerts/Recalls
|