Model Number N/A |
Device Problem
Device Dislodged or Dislocated (2923)
|
Patient Problem
Joint Dislocation (2374)
|
Event Date 04/02/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the hospital would not return.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-01359.
|
|
Event Description
|
It was reported that the patient had an initial wrist surgery on an unknown date.Subsequently, they had a revision due to the carpal side being dislocated from the radial component.The origin dislocated carpal plate with stem and two locking screws and the carpal head were removed.The new augmented carpal plate with stem and two new locking screws and standard carpal head were implanted.Attempts have been made and additional information on the reported event is unavailable at this time.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
(b)(4) reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Search Alerts/Recalls
|