Catalog Number 00902602900 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Host-Tissue Reaction (1297); Reaction (2414)
|
Event Date 01/12/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical devices: part# unknown/ unknown stem/ lot# unknown; part# 32672800701/liner/ lot # unknown; part# unknown/ unknown cup/ lot # unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2021 -00297.
|
|
Event Description
|
It was reported that a patient underwent a hip arthroplasty on an unknown date and subsequently was revised due to pseudo-tumor/metallosis.The head and liner were revised.Attempts have been made and additional information on the reported event is unavailable at this time.
|
|
Manufacturer Narrative
|
Reported event was unable to be confirmed.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 could not 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
|