|
Model Number N/A |
Device Problem
Insufficient Information (3190)
|
Patient Problems
Joint Swelling (2356); Reaction (2414)
|
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Concomitant medical products: bcm-palacos-unknown; p/n: unk, l/n: unk; kne-persona-bearings-unk; p/n: unk, l/n: unk; kne-persona-femorals-unk; p/n: unk, l/n: unk; kne-persona-tibial trays-unk; p/n: unk, l/n: unk; kne-persona-patellas-unk; p/n: unk, l/n: unk.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.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: 0001822565-2019-01259, 0001822565-2019-01326, 0001822565-2019-01327.Product location is unknown.
|
|
Event Description
|
It was reported patient is experiencing an allergic reaction post-implantation.No revision has been reported to date.Attempts to obtain additional information have been made; however, no more is available.
|
|
Manufacturer Narrative
|
(b)(4).The additional information received, no changes to the root cause, the reported event was unable to be confirmed due to limited information received from the customer.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.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay updated and additional information.Reported event was unable to be confirmed due to limited information received from the customer.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 01259 - 1, 0001822565 - 2019 - 01326 - 1, 0001822565 - 2019 - 01327 - 1.
|
|
Search Alerts/Recalls
|
|
|