SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
|
Back to Search Results |
|
Catalog Number 71335756 |
Device Problem
Positioning Failure (1158)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/10/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
Internal reference number: (b)(4).Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.
|
|
Event Description
|
It was reported that during a thr surgery, while placing the r3 3 hole acet shell 56mm and r3 20 deg xlpe acet lnr 36mm x 56mm, implants were not able fixed and locked too.Surgeon tried several times but was not able to be fixed.The procedure was resumed, after a significant delay, with s+n back-up devices.Patient was not injured as consequence of this problem.
|
|
Event Description
|
It was reported that, during a thr surgery, while placing the r3 3 hole acet shell 56mm and r3 20 deg xlpe acet lnr 36mm x 56mm, the implants failed to be fixed and locked.Surgeon tried several times, but it was not possible to position the mentioned components.The procedure was resumed, after a delay greater than 30 min, with s+n back-up devices.Patient was not injured as consequence of this problem.
|
|
Manufacturer Narrative
|
H3, h6: although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the acetabular liner and shell.These devices were not returned for evaluation; therefore, a device analysis could not be performed.However, based on the information provided, the unsatisfactory experience could be confirmed.The devices' batch numbers were not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed devices.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions that could be related to these products and event.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include size selected or insertion technique.Based on this investigation, the need for corrective action is not indicated.Should the devices or 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.We consider this investigation closed.H11- corrected data.B5- describe event or problem.
|
|
Search Alerts/Recalls
|
|
|