MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ECHELON HA STD 260 BOW S 15 L; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CA-P

Catalog Number	71344415
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/31/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient complained on pain in hip, x-rays were taken and stem subsidence was noted.Time was given for shaft fracture to unite before further revision surgery was undertaken.Femoral stem and femoral head were revised.
Additional Manufacturer Narrative
Low grade infection previosuly mentioned has been reported through mdr 1020279-2017-01123.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see attached for the results of our investigation.

• Brand Name: ECHELON HA STD 260 BOW S 15 L
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CA-P
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7032024
• Report Number: 1020279-2017-01029
• Device Sequence Number: 13478330
• Product Code: MEH
• UDI-Device Identifier: 00885556023525
• UDI-Public: 00885556023525
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K023302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 03/02/2018

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: 04/11/2024
• Device Catalogue Number: 71344415
• Device Lot Number: 14CM01567A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/02/2017
• Supplement Date Received by Manufacturer: 11/27/2017; 11/27/2017
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 11/27/2017; 03/02/2018
• 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: COCR 12/14 FEM HEAD 36MM -3, 71303603/(B)(4)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention