MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR MOD HEADS; BHR MODULAR HEAD 44MM

Model Number 74222144

Device Problem Material Integrity Problem (2978)

Patient Problems Swelling (2091); Test Result (2695)

Event Date 06/19/2014

Event Type  Injury  

Event Description

Clinical records indicate that the client sustained metal toxicity and a pseudo tumour involving the acetabular component following total hip replacement (thr) with birmingham hip prosthesis.It is unclear if the date of event refers to a revision surgery.

• Brand Name: BHR MOD HEADS
• Type of Device: BHR MODULAR HEAD 44MM
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; 1 kingmaker court; gallows hill CV34 6WG; UK CV34 6WG
• Manufacturer (Section G): SMITH & NEPHEW; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: michael simmonds ; oberneuhofstrasse 10d; baar; SZ 6340 ; 0628320660
• MDR Report Key: 4208630
• MDR Text Key: 16307130
• Report Number: 3005477969-2014-00546
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2013
• Device Model Number: 74222144
• Device Catalogue Number: 74222144
• Device Lot Number: 08LW20112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: MW1209
• Patient Sequence Number: 1
• Treatment: R3 44MM COCR LINER 56MM: 71335856, LOT 08CW15968
• Patient Outcome(s): Required Intervention