MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HK LINK ASSEMBLY SZ 6-7 FEMORAL; PROS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLY/MET/POLY

Model Number	71421632
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	11/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to a legion-hk femur-/tibia-k-tep inserted from implantation in 2015 dislocated/luxation due to a connector fracture.
Additional Manufacturer Narrative
It was reported that revision surgery was performed due to a connector fracture.The associated complaint devices, used in treatment, were returned and evaluated.A lab analysis conducted during this investigation indicated that the sleeve and hinge are fractured.Deformation of the polyethylene tibial insert, sleeve and hyperextension stop were observed.Wear is noted on the rod, tibial insert, and hinge.There were also signs of scratching on the hinge and bushing.A medical analysis noted that the provided images confirm the breakage but not the reason for the broken component.The information on the implantation/revision reports, bone quality or fall history were not provided.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode.A review of the manufacturing records for the link assembly and the hinge did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident could not be corroborated.Review of the instructions for use and risk management files identified the reported failure as potential adverse events.Possible causes could include but are not limited to traumatic injury, size of device or user/procedural variance.

• Brand Name: LEGION HK LINK ASSEMBLY SZ 6-7 FEMORAL
• Common Device Name: PROS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLY/MET/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9419428
• Report Number: 1020279-2019-04296
• Device Sequence Number: 2491363
• Product Code: JWH
• UDI-Device Identifier: 00885556614655
• UDI-Public: 00885556614655
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K081111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 71421632
• Device Catalogue Number: 71421632
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 03/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71421377/LGN HK FEM ASSEMBLY SZ 7 LT/14EAF011A; 71421648/LGN HK HYPEREXT STOP W/AX PLUG; 71421687/LEGION HINGE 13MM BOLT/12LT002M; 71421938/LGN HK AXLE SZ 7 FEMUR; 71423365/LEGION HK GD MOTION ISRT 13MM SZ 6-7 LT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 88 YR
• Patient Weight: 100