MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REFLECTION PRIMARY L; REF XLPE 28 20 DEG 50-52 E

Catalog Number 71333324

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 11/05/2014

Event Type  Injury  

Event Description

Revision surgery of the hip was reported.Date of implantation approximately 4 years ago.

Manufacturer Narrative

• Brand Name: REFLECTION PRIMARY L
• Type of Device: REF XLPE 28 20 DEG 50-52 E
• 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: carla samuels ; 1450 brooks road; memphis, TN 38116 ; 9013995076
• MDR Report Key: 4263870
• MDR Text Key: 5030166
• Report Number: 1020279-2014-00706
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71333324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/06/2014
• 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: 71342812O
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 45 YR