|
Model Number N/A |
Device Problem
Detachment of Device or Device Component (2907)
|
Patient Problem
Failure of Implant (1924)
|
Event Date 04/18/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Concomitant medical products: catalog #: 00434903606, poly liner plus, lot #: 64375006.Catalog #: 115313, comp rvsr shldr glnsp, lot #: 612700.Catalog #: 010000589, comp rvrs 25mm bsplt ha+adptr r, lot #: 005110.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its device has been discarded.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: 0001822565-2020-02728.
|
|
Event Description
|
It was reported that the patient underwent a total shoulder procedure approximately 5 months ago.Subsequently the patient was revised one month later due to poly disassociation.Attempts have been made and there is no additional information available at this time.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
(b)(4).Updated: b4, b5, d4, g4, h1, h2 corrected: d4 (lot, exp date), h4 the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Manufacturer Narrative
|
(b)(4) updated: b4, b5, d4 (udi), g4, h1, h2, h3, h6, h10.Reported event was confirmed from the review of the x-rays which identified superior dislocation of the humeral component and now abutment of the glenosphere and the calcar with associated bony resorption likely for the 2nd revision.Device history record was reviewed and no discrepancies relevant to the reported event were found.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
|
|
|