MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120156

Device Problems Break (1069); Detachment Of Device Component (1104); Use of Device Problem (1670)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/05/2017

Event Type  malfunction  

Event Description

A bhr cup implant holding wire had a small section broke free intra operatively.The wire broke after the cup was implanted, during removal of the wire.Very short delay while the surgeon retrieved the wire and discussed the issue with sales rep.The wire broke after it was cut and the surgeon was removing it as per procedure, a small section of what looked like clear plastic coating broke off and had to be retrieved from the patient.

• Brand Name: BHR ACETABULAR CUP 56MM
• 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: 7167266
• MDR Text Key: 96592228
• Report Number: 3005975929-2018-00011
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502599
• UDI-Public: 03596010502599
• 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: 11/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2022
• Device Catalogue Number: 74120156
• Device Lot Number: 17EW20938A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2017
• Patient Sequence Number: 1
• Treatment: EXTRACTION KIT, # 900201, LOT # 17EW20938A