MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HK GD MOTION ISRT 15MM SZ 4-5 LT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71423356
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330)
Date of Event	06/27/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a revision surgery to replace the articular insert of total knee system.During check up the doctor noticed the insert screw of the hinge insert wasn't in its original place.Because of pain, laxity and uncomforted feeling the doctor decided to revise the insert of the legion hinge.

• Brand Name: LEGION HK GD MOTION ISRT 15MM SZ 4-5 LT
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6746286
• Report Number: 1020279-2017-00562
• Device Sequence Number: 1371581
• Product Code: KRO
• UDI-Device Identifier: 00885556030271
• UDI-Public: 00885556030271
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K081111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/28/2017

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 Expiration Date: 06/19/2023
• Device Model Number: 71423356
• Device Catalogue Number: 71423356
• Device Lot Number: 04JM10042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Initial Date Received by Manufacturer: 06/27/2017
• Supplement Date Received by Manufacturer: 08/28/2017; 08/28/2017
• Initial Report FDA Received Date: 07/27/2017
• Supplement Report FDA Received Date: 09/01/2017; 11/28/2017
• 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: LEGION HK 15MM BOLT - SLEEVE, 71421387/13BTM0025
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 54 YR