MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR MODULAR HEAD 50MM

Catalog Number 74222150

Device Problems Collapse (1099); Loose or Intermittent Connection (1371)

Patient Problem Toxicity (2333)

Event Date 05/16/2014

Event Type  Injury  

Event Description

It was reported led the customer had a removal of the bhmh system components with the exception of the synergy stem.Initial revision in 2011 due to the implant found to be loose and the femoral head had collapsed.It was replaced with a synergy stem, bhr head and a modular taper sleeve.After this, the customer had blood test which showed metal ions in the blood stream.The customer had a further revision in 2014 to remove the metal implants.

Manufacturer Narrative

Modular sleeve updated part number.

• Brand Name: BHR MODULAR HEAD 50MM
• Type of Device: BHR MODULAR HEAD 50MM
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: claudia odoy ; schachenallee 29; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 5903509
• MDR Text Key: 52973536
• Report Number: 3005477969-2016-00207
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Catalogue Number: 74222150
• Device Lot Number: 09MW25434
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/07/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/28/2010
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR