MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD UNKN BHR MODULAR HEAD SLEEVE; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number UNKNOWN

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Injury (2348)

Event Date 07/08/2016

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision surgery due to pain.The explanted devices were a 52mm bhr cup and a 46mm bhr head.The metal ion levels were chromium in urine : 2.10 h ¿g/g creat.Cobalt in urine: 5 h ¿g/g creat.Metal on whole blood: not detected.The patient outcome is unknown.

Manufacturer Narrative

The part number reported under this event is a concomitant device reported under 3005975929-2020-00169; therefore, this is considered a duplicate report.

• Brand Name: UNKN BHR MODULAR HEAD SLEEVE
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 10105605
• MDR Text Key: 193067578
• Report Number: 3005975929-2020-00171
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention