Model Number 15-8524/52 |
Device Problems
Fracture (1260); Loss of Osseointegration (2408)
|
Patient Problems
Failure of Implant (1924); Pain (1994)
|
Event Date 10/17/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.
|
|
Event Description
|
Crepitus in the area of tumor endoprosthesis, on (b)(6) 2020 crackling sound without trauma and sudden acute pain and instability, material fracture of the femoral prosthesis shaft of a tumor endoprosthesis after implantation 2013 in otherwise normally active patients.[reported by user].
|
|
Manufacturer Narrative
|
The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.
|
|
Event Description
|
Crepitus in the area of tumor endoprosthesis, on (b)(6) 2020 crackling sound without trauma and sudden acute pain and instability, material fracture of the femoral prosthesis shaft of a tumor endoprosthesis after implantation 2013 in otherwise normally active patients.[reported by user].
|
|
Search Alerts/Recalls
|