MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HK 11MM BOLT - SLEEVE; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71421385

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 11/15/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to a legion hk's axle break.

Manufacturer Narrative

The affected legion hk guided motion insert and legion hinge sleeve were not returned for evaluation.As the devices were not made available for investigation, the failure mode cannot be determined or confirmed.However, batch number was provided for both devices.Thus, a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.Our investigation including a review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode.There is no information that would suggest the implanted devices failed to meet specifications.A clinical evaluation noted that the photos, in addition to the x-rays were reviewed but do not indicate the reason for the breakage.Without the requested clinical information or the explant, the root cause of the implant fracture cannot be determined.The future impact to the patient beyond the revision cannot be determined.No further clinical/medical assessment is warranted at this time.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.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: LEGION HK 11MM BOLT - SLEEVE
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8108151
• MDR Text Key: 128556487
• Report Number: 1020279-2018-02621
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00885556029213
• UDI-Public: 00885556029213
• Combination Product (y/n): N
• PMA/PMN Number: K081111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71421385
• Device Lot Number: 16JTM0109B
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR