MAUDE Adverse Event Report: DEPUY DEPUY; FEMORAL STEM INSERTER

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/11/2016

Event Type  malfunction  

Event Description

Pt underwent a left total hip arthroplasty.While using the mallet to place the femoral component, the tip broke off of the depuy handle (femoral stem inserter).Tip was unable to be retrieved as it fell into femoral stem.

• Brand Name: DEPUY
• Type of Device: FEMORAL STEM INSERTER
• Manufacturer (Section D): DEPUY
• MDR Report Key: 5795194
• MDR Text Key: 49668796
• Report Number: MW5063389
• Device Sequence Number: 1
• Product Code: LPH
• 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: 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/11/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR