Model Number N/A |
Device Problem
Biocompatibility (2886)
|
Patient Problems
Inflammation (1932); Metal Related Pathology (4530)
|
Event Date 01/09/2024 |
Event Type
Injury
|
Event Description
|
It was reported that patient underwent revision post implantation due to metal ion reaction with pseudotumor formation and liquid collection of inflammatory material.Attempts have been made and additional information on the reported event is unavailable at this time.
|
|
Manufacturer Narrative
|
(b)(4).G2: report source italy.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will besubmitted.Multiple mdr reports were filed for this event, please see associated reports: mdr355165, mdr355170.
|
|
Manufacturer Narrative
|
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, d4, d9, g3, g6, h2, h3, h4, h10.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.
|
|
Manufacturer Narrative
|
(b)(4).This follow-up report is being submitted to relay additional information.The head adapter was returned for investigation.The inner surface of the head adaptor shows surface changes in form of fretting corrosion.A review of the device manufacturing records for the head adapter confirmed no abnormalities or deviations that could be related to the reported event.A review of the device manufacturing records for the cup could not be performed due to missing lot number.Review of the complaint histories for the head adapter identified additional similar complaints for the reported items and the part and lot combinations.Complaints are monitored per complaint trending process in order to identify potential adverse trends.With the available information, a definitive root cause could not be determined.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
|