MAUDE Adverse Event Report: DEPUY DEPUY HEAD; HIP IMPLANT HEAD

Device Problem Nonstandard Device (1420)

Patient Problem No Code Available (3191)

Event Date 02/24/2014

Event Type  malfunction  

Event Description

Pt is having a revision total hip due to a recall of depuy asr.The cup liner and head are being revised.

• Brand Name: DEPUY HEAD
• Type of Device: HIP IMPLANT HEAD
• Manufacturer (Section D): DEPUY
• MDR Report Key: 3658236
• MDR Text Key: 17387981
• Report Number: MW5034768
• Device Sequence Number: 3
• Product Code: KWY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/24/2014
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/25/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR