Device Problem
Loose or Intermittent Connection (1371)
|
Patient Problem
No Information (3190)
|
Event Date 06/28/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
This event report was received through clinical data collection activities.Pending evaluation.
|
|
Event Description
|
Index surgery: (b)(6) 2013.Revision due to aseptic loosening.The case report form indicates these events are unlikely related to devices and possibly related to procedure.
|
|
Manufacturer Narrative
|
This event report was received through clinical data collection activities.Engineering evaluation noted that the revision reported was likely the result of glenoid loosening caused by the patient's fall.However, this cannot be confirmed as the device was not available for evaluation.
|
|
Event Description
|
Index surgery: (b)(6) 2013.Revision due to aseptic loosening.The case report form indicates these events are unlikely related to devices and possibly related to procedure.
|
|
Search Alerts/Recalls
|