MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HK GD MOTION ISRT 15MM SZ 6-7 RT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	OR71423368
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	04/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implant date: is an approximation based on information provided to us.
Event or Problem Description
It was reported that at the patients 6 month check the doctor noticed that the insert screw is not connected to the tibial base plate anymore.
Additional Manufacturer Narrative
It was additionally communicated that surgeon decided to make no actions to solve the reported issue at the moment, with patient's history being a contributing factor not to operate.Surgeon will see the patient in half a year for a check-up.

• Brand Name: LEGION HK GD MOTION ISRT 15MM SZ 6-7 RT
• 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: 6607489
• Report Number: 1020279-2017-00388
• Device Sequence Number: 1123108
• Product Code: KRO
• UDI-Device Identifier: 00885556108635
• UDI-Public: 00885556108635
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/21/2019
• Device Catalogue Number: OR71423368
• Device Lot Number: 09EM12875
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2017
• Supplement Date Received by Manufacturer: Not provided; 06/08/2017
• Initial Report FDA Received Date: 06/02/2017
• Supplement Report FDA Received Date: 06/12/2017; 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1