MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR HEADS; RESURFACING FEMORAL HEAD 50MM

Model Number 74121150

Device Problems Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Osteolysis (2377); Chemical Exposure (2570); Test Result (2695)

Event Date 09/20/2014

Event Type  Injury  

Event Description

It was reported that a revision has occurred due to femoral neck fracture.During procedure, metallosis and osteolysis was discovered on the femoral neck and acetabulum.

• Brand Name: BHR HEADS
• Type of Device: RESURFACING FEMORAL HEAD 50MM
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; 1 kingmaker court; gallows hill CV34 6WG
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora, spa park, harrison way; leamington spa; gallows hill CV31 3HL; UK CV31 3HL
• Manufacturer Contact: tina mueller ; oberneuhofstrasse 10d; baar; SZ 6340 ; 0417662278
• MDR Report Key: 4137420
• MDR Text Key: 4913749
• Report Number: 3005477969-2014-00517
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2012
• Device Model Number: 74121150
• Device Catalogue Number: 74121150
• Device Lot Number: 71832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/20/2014
• Date Device Manufactured: 02/05/2007
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 69