Model Number N/A |
Device Problem
Material Protrusion/Extrusion (2979)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Event Description
|
It was reported that the sales rep checked multiple sets and noted that these femoral trials all have a protrusion on them.No additional issues were noted.Attempts have been made and all available information has been provided.
|
|
Manufacturer Narrative
|
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001822565-2024-00020.0001822565-2024-00021.0001822565-2024-00022.0001822565-2024-00023.0001822565-2024-00024.0001822565-2024-00025.0001822565-2024-00026.0001822565-2024-00027.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.Upon receipt of additional information, it was determined that the zimmer biomet device did not cause or contribute to the reported event.Review of the femoral trial print compared to the implant print identified the radius as different by design.The evaluation of product drawing print identified the differing of the provisional and implant are within specification and hence no issue with the device was seen.The initial report should be voided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Search Alerts/Recalls
|