MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122154

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 03/28/2019

Event Type  malfunction  

Event Description

Wire holding the cup to the impactor broke when positioning the cup into the acetabulum, before impaction.As a result the cup could not be implanted.Surgeon reamed up to 56mm and twice attempted to use 74122156.As a result of the increased reaming it was found that the posterior wall of the acetabulum had become too thin to hold the bhr cup, at this stage the only option remaining was to convert to a total hip replacement using an acetabular cup with additional screw fixation.48mm head had already been opened.Replacement of 1x 74122156 urgently requested.Other items were from loan and customer services have already been made aware.

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 ACETABULAR CUP 54MM
• 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: 8553906
• MDR Text Key: 143446752
• Report Number: 3005975929-2019-00182
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552297
• UDI-Public: 03596010552297
• 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: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2023
• Device Catalogue Number: 74122154
• Device Lot Number: 18BW19013
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/28/2019
• Patient Sequence Number: 1