MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION PS NP FEM SZ 3 RT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71423233
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to discomfort.The femoral component and insert were replaced.The surgeon stated that the cause of this failure was malalignment of the femoral component.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: LEGION PS NP FEM SZ 3 RT
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8489976
• Report Number: 1020279-2019-01416
• Device Sequence Number: 11207830
• Product Code: JWH
• UDI-Device Identifier: 00885556030721
• UDI-Public: 00885556030721
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2019

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 Catalogue Number: 71423233
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/07/2019
• Supplement Report FDA Received Date: 10/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention