MAUDE Adverse Event Report: SMITH-NEPHEW BIRMINGHAM HIP RESURFACING SYSTEM; HIP IMPLANT

Device Problems Device Slipped (1584); Malposition of Device (2616)

Patient Problems Necrosis (1971); Toxicity (2333)

Event Date 05/14/2013

Event Type  Injury  

Event Description

On (b)(6) 2008 my right hip was resurfaced using the smith-nephew birmingham hip resurfacing system at (b)(6).(b)(6) was the attending physician.On (b)(6) 2013 the resurfacing was revised to a total hip replacement due to failure of the resurfacing system at (b)(6).(b)(6) was the attending physician.Prior to the revision surgery, cobalt was 98.4 ug/l and chromium was 65.5 ug/l.During the revision surgery it was noticed that the cup was mis positioned and the ball was loose.Bone tissue adjacent to the implant was osteonecrotic.

• Brand Name: BIRMINGHAM HIP RESURFACING SYSTEM
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): SMITH-NEPHEW
• MDR Report Key: 4025045
• MDR Text Key: 17991736
• Report Number: MW5037795
• Device Sequence Number: 1
• Product Code: NXT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 97