MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HINGE 11MM TRIAL POST; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71434395

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2023

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during a trail stage of hk procedure, the leg was not reaching full extension.The trials used were: legion hinge tib base trl sz 5 rt, legion hinge 11mm trial post and lgn hinge trial link sz 6-7.With the trial impinging and blocking the knee from achieving full extension, it appeared like the knee was unbalanced and tight in extension therefore bone re cuts were made to balance the knee.They re-cut the femur and re-trial, but there was no improvement.Also they re-cut the tibia and re-trial and there was no improvement.But these re-cuts made no difference to the rom of the knee.Gap assessment tool indicated that there should be not issue achieving full extension.However the surgeon then suggested the trial itself was mechanically restricting the rom.Trail was removed and reconstructed outside the patient and confirmed that the trail was limiting the extension.The procedure was completed.After the case the rep rebuilt with assistance from a member of the theatre team, with a couple of failed attempts with the same issue.The trial was assembled with normal function.Therefore it was determined that the bolt at some point had been cross-threaded and if it was assembled in that position it restricts the motion of the trial link and stops full extension being achieved.The procedure was resumed, after a significant delay, using the same device.Patient was not harmed as consequence of this problem.

Manufacturer Narrative

H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the device did not reveal similar events for the listed device.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 related to these products and event.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.With the results of this investigation the root cause of this event could not be determined.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to 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 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.

• Brand Name: LEGION HINGE 11MM TRIAL POST
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16277854
• MDR Text Key: 308847920
• Report Number: 1020279-2023-00211
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00885556033791
• UDI-Public: 00885556033791
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71434395
• Device Catalogue Number: 71434395
• Device Lot Number: 13HEM0011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/07/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1