Model Number N/A |
Device Problem
Material Erosion (1214)
|
Patient Problem
Pain (1994)
|
Event Date 08/01/2009 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Medical devices: unk head, unk stem.Report source- mw5081307.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-11225.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 that underwent a revision procedure approximately 11 years post implantation due to elevated metal levels and pain.The patient suffered from high blood metal levels, nose bleeds, nausea, migraines, weight loss and memory loss.No additional information available.
|
|
Manufacturer Narrative
|
Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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
|
No further event information available at the time of this report.
|
|
Search Alerts/Recalls
|