MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HK GD MOTION ISRT 11MM SZ 4-5 RT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED

Catalog Number 71423353

Device Problem Off-Label Use (1494)

Patient Problem Injury (2348)

Event Date 05/04/2017

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed to exchange a right knee insert that was implanted into the left knee.

Manufacturer Narrative

It was confirmed that no revision has been performed, contrary to previous reports.The patient has 100 degrees of flexion and is walking fine.No revision surgery will be performed.

Event Description

It was reported that no revision surgery has been performed and that the patient is doing great post-op.No revision surgery will be performed.

• Brand Name: LEGION HK GD MOTION ISRT 11MM SZ 4-5 RT
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: robert rust ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 6795208
• MDR Text Key: 82714873
• Report Number: 1020279-2017-00631
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00885556108703
• UDI-Public: 00885556108703
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K081111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 71423353
• Device Lot Number: 15EM07257
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 71421304; 71421375
• Patient Outcome(s): Hospitalization; Required Intervention