MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR MODULAR HEAD 40MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74222140

Device Problems Degraded (1153); Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/10/2017

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to a metal debris reaction.

Manufacturer Narrative

Smith + nephew is submitting this report pursuant to the provisions of 21cfr, part 803.This report may be based upon information which smith + nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith + nephew, or its employees, that the report constitutes an admission that the device, smith + nephew or its employees caused or contributed to the potential event described in this report.

• Brand Name: BHR MODULAR HEAD 40MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 9214312
• MDR Text Key: 163024491
• Report Number: 3005975929-2019-00379
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2013
• Device Catalogue Number: 74222140
• Device Lot Number: 08JW19089
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODULAR SLEEVE -4MM 12/14 74222100/08EW169559.; R3 0 HOLE ACET SHELL 52MM 71331852/09CM00012.; R3 40MM ID INTL COCR LINER 52MM 71335852/08GW18016.; REF THREADED HOLE COVER 71336500/09GM08239.; SYN POR FEM COMP SZ 11 71306611/08KM21838.; MODULAR SLEEVE -4MM 12/14 74222100/08EW169559; R3 0 HOLE ACET SHELL 52MM 71331852/09CM00012; R3 40MM ID INTL COCR LINER 52MM 71335852/08GW18016; REF THREADED HOLE COVER 71336500/09GM08239; SYN POR FEM COMP SZ 11 71306611/08KM21838
• Patient Outcome(s): Required Intervention
• Patient Weight: 82