|
Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Inflammation (1932); Pain (1994); Swelling (2091); Alteration In Body Temperature (2682)
|
Event Date 08/08/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Concomitant medical products: 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.Kne-persona-stems-unkt; 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: 0001822565-2019-04052, 0001822565-2019-04053, 0001822565-2019-04055.Device evaluated by manufacturer? remains implanted.
|
|
Event Description
|
It was reported the patient is experiencing pain, swelling, knee getting cold plus hot continually and inflammation after initial surgery.Subsequently, a revision is scheduled for a later time.However, no revision procedure has been reported to date.No further information is available.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay updated and additional information.D11 - medical products patella, item #: unknown lot #: 87524706g17.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.
|
|
Search Alerts/Recalls
|
|
|