Model Number N/A |
Device Problems
Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
|
Patient Problem
No Code Available (3191)
|
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation since the device remains implanted in the patient.The investigation is in process.Once the investigation has been completed, a follow up mdr will be submitted.
|
|
Event Description
|
It was reported that the patient underwent an initial hip arthroplasty on an unknown date.Subsequently, the patient is being indicated for a revision due to loosening.However, no revision has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.
|
|
Event Description
|
It was reported that the patient underwent an initial right hip arthroplasty on an unknown date.Subsequently the patient has been revised due to wear.Attempts have been made and additional information on the reported event is unavailable.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information. .
|
|
Search Alerts/Recalls
|