SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 36MM X 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
|
Back to Search Results |
|
Model Number 71332754 |
Device Problem
Positioning Problem (3009)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/02/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
It was reported that, despite several attempts, the r3 liner could not be inserted in the cup.A second liner (a s+n backup device) fit in the first attempt.A surgical delay of 30 min or less was reported.No harm to the patient was reported.
|
|
Manufacturer Narrative
|
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device has minor scratches on the surface of device.The device shows signs of extensive use.A functional evaluation confirmed that the mating part fails to insert properly, which would cause the device not to 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 this device 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.Results of investigation corrected.
|
|
Manufacturer Narrative
|
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device has minor scratches on the surface of device.The device shows signs of extensive use.A functional evaluation confirmed that the mating part fails to insert properly, which would cause the device not to 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 do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable and crack may have initiated during use and possible causes could be due to the heating and cooling associated with autoclaving or prolonged use.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further actions are being taken at this time.We consider this investigation closed.
|
|
Search Alerts/Recalls
|
|
|