MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION TRIAL STEM 12 X 160; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71434045

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2019

Event Type  malfunction  

Event Description

It was reported that when starting a primary surgery at a patient with severe varus deformation, when the nurse tried to prepare the instruments, it was noted that the instrument was not clean inside, after multiple cleaning and disinfection in the rdg, this shown to have rough remedies and residual proteins.The patient had already a spinal anesthesia, and the planned surgery had to be canceled due to this issue.

Manufacturer Narrative

The associated legion trial stems, legion offset coupler trials were not returned for evaluation.However, device details were provided.Thus, a review of device history record and complaint history were performed.The review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.The review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.There is no information that would suggest the devices failed to meet specifications.A relationship, if any, between the devices and the reported incident could not be corroborated.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.We recommended cleaning method given in our new cleaning and sterilization brochure ¿instructions for care, maintenance, cleaning and sterilization of smith & nephew orthopaedic devices¿ issued in 2018.Should the device or additional information be received, this complaint will be reopened and reevaluated.Without the return of the actual product involved, our investigation of this report is inconclusive.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.

Manufacturer Narrative

The devices were not returned for evaluation.The complaint indicated the instruments could not be reprocessed cleanly.It¿s alleged that despite manual cleaning, residual proteins were left on the devices.Manufacturing records review for the listed batches did not reveal any deviations from standard manufacturing processes.These devices were manufactured in 2014 and 2015, which suggests they have been in use for some time.With this amount of service time, these instruments would be susceptible to damage from repeated use or contact with other metallic instrumentation.Complaint history review against these devices found no other complaints for cleaning issues.A relationship, if any, between the devices and the reported incident, could not be established.These are reusable medical devices, which may require detailed processing after use.Following instructions provided in ¿instructions for care, maintenance, cleaning, and sterilization of smith & nephew orthopedic devices¿ will minimize the risk of infectious agents being transmitted.Smith and nephew recommend that with instrumentation that may have challenging designs the features be moved and/or retracted so a brush can be used to remove debris.It is further recommended that with difficult to view design features, an application of 3% hydrogen peroxide be used to verify cleanliness.If bubbling occurs, it indicates the presence of blood and additional cleaning is required.Damage can occur without warning on reusable instruments and they should be evaluated prior and after usage.When they can no longer be maintained clean they should be replaced.Instrumentation end of life is normally determined by wear and damage due to use.Smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the devices or additional information be received, this complaint will be reopened and reevaluated.Without the actual product, our investigation is inconclusive.

• Brand Name: LEGION TRIAL STEM 12 X 160
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8357490
• MDR Text Key: 136739334
• Report Number: 1020279-2019-00718
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010547699
• UDI-Public: 03596010547699
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71434045
• Date Manufacturer Received: 01/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1