ZIMMER BIOMET, INC. G7 OSSEOTI ACETABULAR SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER
|
Back to Search Results |
|
Catalog Number 110010247 |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
|
Patient Problems
Bone Fracture(s) (1870); Joint Dislocation (2374)
|
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00329.D10: item# 51-103140; lot# 6626648.Item# 650-1057; lot# 2958797.Item# 650-1068; lot# 2965056.Item# 30103607; lot# 64358597.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Dhr was reviewed and no discrepancies relevant to the reported event were found.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: acetabuli protrusio of the acetabular component with subsidence of the femoral component and dislocation of the femoral head.Fracture superomedial and anterior acetabulum.A definitive root cause cannot be determined.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.
|
|
Event Description
|
It was reported by the pmi group that a patient underwent a right hip arthroplasty on an unknown date.Subsequently, the patient is being considered for a pmi product on an unknown day for an unknown reason.X-rays received and reviewed, noting loosening of the acetabular component, subsidence of the femoral component, dislocation of the femoral head, and bone fracture of the acetabulum.Attempts have been made and no further information has been provided.
|
|
Search Alerts/Recalls
|
|
|