SMITH & NEPHEW, INC. MI TRIAL FEM HEAD 36 +8; PROSTHESIS,HIP,SEMICONSTRAINED,METALCERAMICPOLYMER,CEMENTEDORNON-POROUS
|
Back to Search Results |
|
Model Number 75100858 |
Device Problems
Break (1069); Crack (1135)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/16/2021 |
Event Type
malfunction
|
Event Description
|
It was reported that a trial femoral head 36 l/+8 has cracked and broken sections.As this was noticed in a non-surgical environment, there was no patient involvement.
|
|
Manufacturer Narrative
|
Internal complaint reference case (b)(4).
|
|
Manufacturer Narrative
|
(b)(4).D1: brand name updated.D4: catalog number and udi updated.
|
|
Manufacturer Narrative
|
Results of investigation: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device is cracked and gouged rendering the device inoperative.A review of complaint history revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are probable causes of the reported event.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 investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.
|
|
Search Alerts/Recalls
|
|
|