Model Number N/A |
Device Problems
Difficult to Insert (1316); Device Operates Differently Than Expected (2913)
|
Patient Problem
No Information (3190)
|
Event Date 06/19/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).The customer has indicated that the product will not be returned to zimmer biomet for investigation, as no additional information can be provided concerning the event.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
It is reported that the surgeon attempted three times to assemble the humeral tray with the polyethylene liner during reverse shoulder arthroplasty, but the locking ring of the humeral tray did not expand properly.No further information has been received for this event.
|
|
Manufacturer Narrative
|
Concomitant medical products: unknown comprehensive reverse humeral bearing, part# unk lot# unk.Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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
|