Model Number REVERS 36MM CA ADAPTER ASSEMBLY |
Device Problem
Failure to Advance (2524)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/26/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.
|
|
Event Description
|
On (b)(6)2024, it was reported by a sales representative via email that an ar-9502-36arca univers revers ca humeral head adapter 36 was attempted to be attached to the cup.Unable to marry the two products successfully.This was discovered during a rtsa revision case where a ca head was implanted.The case was completed with another ar-9502-36arca with no patient harm.Additional information received 2/28/24: the reason for the revision surgery was that the patient had stryker hardware in from a previous rtsa which was infected.The case was delayed roughly 10 minutes.
|
|
Manufacturer Narrative
|
The complaint allegation was not confirmed.One unpacked ar-9502-36arca serial/batch number (b)(6) was received for investigation.Upon evaluating the received device, it was found signs of wear.Functional testing with the matting part ar-9502f-36cpc batch 16.01252 found not issues attaching the univers revers¿ ca humeral head adapter 36 to the cup.No problem found.
|
|
Search Alerts/Recalls
|