MAUDE Adverse Event Report: SMITH & NEPHEW, INC; PROSTHESIS, HIP, FEMORAL HEAD

Catalog Number 74122546

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Date 09/25/2013

Event Type  malfunction  

Event Description

Right hip femoral component grossly loose; also, metal-on-metal component replaced.

• Type of Device: PROSTHESIS, HIP, FEMORAL HEAD
• Manufacturer (Section D): SMITH & NEPHEW, INC; 150 minuteman rd; andover MA 01810
• MDR Report Key: 3700247
• MDR Text Key: 4337460
• Report Number: 3700247
• Device Sequence Number: 2
• Product Code: JDH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/18/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 74122546
• Device Lot Number: 08HW18246
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/20/2014
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 83