MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR; ACETABLR CUP

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Seroma (2069); Weakness (2145); Complaint, Ill-Defined (2331)

Event Date 03/28/2014

Event Type  Injury  

Event Description

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

• Brand Name: BHR
• Type of Device: ACETABLR CUP
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; 1 kingmaker court; gallows hill CV34 6WG; UK CV34 6WG
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora, spa park, harrison way; leamington spa; warwick CV31 3HL; UK CV31 3HL
• Manufacturer Contact: tina mueller ; oberneuhofstrasse 10d; baar; SZ 6340 ; 0628320660
• MDR Report Key: 4368589
• MDR Text Key: 20773158
• Report Number: 3005477969-2014-00617
• 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: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• 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: 12/11/2014
• 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: BHR SLVD MODULAR HEAD
• Patient Outcome(s): Hospitalization; Required Intervention