|
Model Number 24MM BASEPLATE, MODULAR |
Device Problems
Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)
|
Patient Problem
Failure of Implant (1924)
|
Event Date 05/04/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
|
|
Event Description
|
It was reported that the post-op images show either the ar-9560-24 glenosphere not fully engaged on the ar-9564-2433-lat baseplate (even though the locking screw fully engaged to 4nm), or the baseplate is a +4 lateralized baseplate and was mislabeled.See source data and x-ray image attached.Additional information received on 5/17/2021: the rep reported the there were no issues/deviations during the procedure when attempting to engage the glenosphere and baseplate and everything engaged as it normally would.The issue was noticed on the same day the products were implanted while taking post-op images.The rep reported the revision surgery took place on (b)(6) 2021.Additional information received on 5/17/2021: the rep reported only the glenosphere screw was explanted.The surgeon re-impacted the glenosphere to ensure tapper seeding, then replaced the glenosphere screw.The only available x-ray copies are pre-revision.There are no post revision images available.Pending confirmation on part/lot number of explanted glenosphere screw.
|
|
Search Alerts/Recalls
|
|
|