Catalog Number 110031399 |
Device Problem
Device Dislodged or Dislocated (2923)
|
Patient Problem
Failure of Implant (1924)
|
Event Date 12/20/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-00076.
|
|
Event Description
|
It was reported that the glenosphere disassociated from baseplate.No additional information is available at this time.
|
|
Event Description
|
It was reported that the glenosphere disassociated from baseplate.No additional information is available at this time.
|
|
Manufacturer Narrative
|
(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-00076.
|
|
Manufacturer Narrative
|
Upon reassessment of the reported event, the device was determined to be not reportable.The initial report was forwarded in error and should be voided.
|
|
Event Description
|
Upon reassessment of the reported event, the device was determined to be not reportable.The initial report was forwarded in error and should be voided.
|
|
Search Alerts/Recalls
|