MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR; ACETLR CUP HAP 50MM W/ IMPTR

Model Number 74120150

Device Problem Metal Shedding Debris (1804)

Patient Problems Complaint, Ill-Defined (2331); Toxicity (2333)

Event Date 05/12/2014

Event Type  Injury  

Event Description

The client had a birmingham hip resurfacing in late 2005 complicated by femoral neck fracture approximately 2 years later.

Event Description

It was reported that a client in (b)(6) sustained metal toxicity and a right hip pseudo tumour.It is unclear if a revision surgery has been performed yet.

• Brand Name: BHR
• Type of Device: ACETLR CUP HAP 50MM W/ IMPTR
• 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 ; 4419264823
• MDR Report Key: 4180407
• MDR Text Key: 5079413
• Report Number: 3005477969-2014-00536
• 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
• Type of Report: Initial,Followup
• Report Date: 12/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2009
• Device Model Number: 74120150
• Device Catalogue Number: 74120150
• Device Lot Number: 36157
• 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: 07/12/2004
• 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: RESURFACING FEMORAL HEAD 42MM: 74121142, LOT 37263
• Patient Outcome(s): Required Intervention