MAUDE Adverse Event Report: SMITH & NEPHEW BHR; ACETABULAR CUP

Device Problem Metal Shedding Debris (1804)

Patient Problems Pain (1994); Weakness (2145); Toxicity (2333); Fluid Discharge (2686); Test Result (2695)

Event Date 07/14/2014

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed.Pain, weakness of the legs and hips, elevated cobalt and chromium levels and fluid accumulations around the hip were reported.

Manufacturer Narrative

• Brand Name: BHR
• Type of Device: ACETABULAR CUP
• Manufacturer (Section D): SMITH & NEPHEW; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: michael simmonds ; 4419264823
• MDR Report Key: 4643085
• MDR Text Key: 5615485
• Report Number: 3005477969-2015-00097
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/24/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HEMI HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention