Model Number N/A |
Device Problem
Fracture (1260)
|
Patient Problem
No Information (3190)
|
Event Date 08/27/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-03497.Medical devices: oss poly bumper lock pin catalog#: 150510 lot#: 908890, oss reinforced yoke catalog#: 150493 lot#: 554600, oss axle catalog#: 150480 lot#: 286100, oss poly femoral bushings catalog#: 150477 lot#: 936210, oss poly tibial bushing catalog#: 150476 lot#: 233540.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
It was reported the patient underwent a knee revision a few weeks after a fall due to implant fracture.No additional patient consequences were reported.Attempts have been made and no further information has been provided.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
Upon reassessment of the reported event, it was identified that this device did not cause or contribute to the reported event.
|
|
Event Description
|
Upon reassessment of the reported event, it was identified that this device did not cause or contribute to the reported event.
|
|
Search Alerts/Recalls
|