SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 28MM X 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
|
Back to Search Results |
|
Model Number 71334946 |
Device Problem
Incomplete or Inadequate Connection (4037)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/27/2021 |
Event Type
malfunction
|
Event Description
|
It was reported that during thr surgery the r3 20 degrees xlpe acet lnr 28 mm x 46mm insert couldn't be locked.It was used a smith and nephew back up device.It is unkn own if there was any injury or a delay.
|
|
Manufacturer Narrative
|
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device has scratches and nicks on the surface and inside device.The device was manufactured in 2019 and shows signs of extensive use.A functional evaluation confirmed that the device was paired with mating part mechanism and does not function as intended.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.The potential probable causes for this event could include but not limited to a user or procedural error.Based on this investigation, the need for corrective action is not indicated.Without the actual products involved and/or device information, our investigation cannot proceed.If these devices or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.
|
|
Search Alerts/Recalls
|
|
|