Model Number N/A |
Device Problem
Detachment of Device or Device Component (2907)
|
Patient Problem
Failure of Implant (1924)
|
Event Date 10/09/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).D10: 110031012.- item name: vivacit-e dm bearing 28x44mm.Lot #: 65587802.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
|
|
Event Description
|
It was reported that the patient underwent a revision procedure 8 months post implantation due to the mobility head disassociating from the bearing.There is no additional information available at the time of this report.
|
|
Event Description
|
There is no update to the prior event description provided.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected h6 component code: mechanical (g04) - head.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Unable to confirm complaint as no product was returned or medical records were provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.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.
|
|
Search Alerts/Recalls
|