MAUDE Adverse Event Report: SMITH AND NEPHEW SMITH & NEPHEW; FEMORAL HEAD

Model Number XLPE INSERT

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Arthralgia (2355); Joint Dislocation (2374); Ambulation Difficulties (2544)

Event Date 03/10/2016

Event Type  Injury  

Event Description

Pt unsure, but did something recently when playing with grandchildren that caused pain in left hip and inability to walk.Denies fall.Dislocated hip had to be revised.Original femoral head and liner replaced.

• Brand Name: SMITH & NEPHEW
• Type of Device: FEMORAL HEAD
• Manufacturer (Section D): SMITH AND NEPHEW
• MDR Report Key: 5529009
• MDR Text Key: 41313351
• Report Number: MW5061270
• Device Sequence Number: 0
• Product Code: MRA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/11/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Device Operator: No Information
• Device Expiration Date: 07/01/2022
• Device Model Number: XLPE INSERT
• Device Catalogue Number: 11 00 602
• Device Lot Number: B1508498
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/23/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 69