SMITH & NEPHEW, INC. LGN HK LINK ASSY SZ 2-5 FEM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 71421631 |
Device Problem
Component Missing (2306)
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Patient Problems
Failure of Implant (1924); Joint Laxity (4526)
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Event Date 08/19/2020 |
Event Type
Injury
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Event Description
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It was reported that, during surgery, there was a doubt if there could be a part missing from the custom implant, however surgeon was told that the device was correct and procedure continued as planned.Once the procedure was concluded, information was received that the bushing was missing from the device.A revision surgery was performed next day to add the hyper extension bushing.The current status of the patient is unknown.
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Manufacturer Narrative
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H3, h6: the device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms based on the information provided, the root cause was reportedly human error secondary to unfamiliarity with the custom-made hk and responsibility in obtaining/assembling the required additional standard components prior to the procedure.It was reported that actions have been instituted to mitigate similar future events involving the manufacture/assembly/shipping of custom hk components.The patient impact beyond the reported joint laxity, modified surgical procedure, and subsequent revision to insert the hyperextension stop into the femoral component could not be determined.No further medical assessment can be rendered at this time.Should clinical documentation/additional information become available, the clinical/medical task may be re-evaluated.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Possible probable cause could include but not limited the user error.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the 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.
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