Model Number ARS655200 |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/08/2020 |
Event Type
Injury
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Manufacturer Narrative
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Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
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Event Description
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It was reported that the patient underwent a reverse total shoulder arthroplasty.Allegedly, the locking cap cross threaded within the size 15 proximal body and wouldn't allow the tray to capture the morse taper.Had to take out the failed implant and replace with a new implant.No patient complications were reported despite an hour delay in surgery.
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Event Description
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It was reported that the patient underwent a reverse total shoulder arthroplasty.Allegedly, the locking cap cross threaded within the size 15 proximal body and wouldn't allow the tray to capture the morse taper.Had to take out the failed implant and replace with a new implant.No patient complications were reported despite an hour delay in surgery.
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Manufacturer Narrative
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Additional information d9, h3, h6.H6: the proximal body was returned for review.A functional analysis was performed using another locking cap.The locking cap was unable to be threaded into the returned proximal body.Upon further analysis, it appears when the initial locking cap was assembled to the proximal body it cross threaded and ruined the threads in the proximal body.
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Search Alerts/Recalls
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