SMITH & NEPHEW, INC. REF THREE HOLE SHELL 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
|
Back to Search Results |
|
Model Number 71336454 |
Device Problem
Connection Problem (2900)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 10/29/2019 |
Event Type
malfunction
|
Event Description
|
It was reported that during a tka procedure, after the acetabular cup was implanted, the liner could not be locked.Another backup s&n cup was used to complete the surgery (no additional cuts were made for the change).There was a delay of 31 to 60 min, but there was no impact to the patient because of it.
|
|
Manufacturer Narrative
|
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device has signs of damage from the attempted implantation and extraction.The device was manufactured in 2018.A dimensional inspection was performed and could not confirm the stated failure mode.The device measured within specification.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 product failed to meet any product specifications at the time of manufacture.Some potential probable causes of the reported event could include poor insertion technique or surgical debris between the mating surfaces.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.
|
|
Search Alerts/Recalls
|
|
|