ARTHREX, INC. UNIVERS VAULTLOCK GLENOID TRIAL, LARGE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
|
Back to Search Results |
|
Model Number UNIVERS VAULTLOCK GLENOID TRIAL, LARGE |
Device Problem
Break (1069)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/16/2022 |
Event Type
malfunction
|
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 on 11/16/2022 by a sales representative via sems that an ar-9236-03pp glenoid trial pegs broke off during a case.Case involvement, broke during use.
|
|
Manufacturer Narrative
|
Complaint confirmed.Upon visual inspection, it was noted that both posts of the device were broken off.The posts were not returned for investigation.The cause remains undetermined, however a probable cause can be attributed to damage incurred during the insertion and/or removal process.
|
|
Search Alerts/Recalls
|
|
|