ARTHREX, INC. UNIVERS VAULTLOCK GLENOID TRIAL, LARGE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
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Model Number UNIVERS VAULTLOCK GLENOID TRIAL, LARGE |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/27/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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On 10/31/2022, it was reported by a sales representative via email that an ar-9236-03pp univers vaultlock¿ glenoid trial central peg snapped off.This was discovered during an ats procedure on (b)(6) 2022,.
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Manufacturer Narrative
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Complaint confirmed.Upon visual investigation, it was noted that the central post is broken.However, the post was not returned for evaluation.The cause remains undetermined.
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Search Alerts/Recalls
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