MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR HEMI HEAD 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74123148

Device Problems Material Disintegration (1177); Fracture (1260); Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Injury (2348); No Code Available (3191)

Event Date 10/27/2013

Event Type  Injury  

Event Description

It was reported that patient underwent a revision surgery for left hip due to metal debris, and femoral neck fracture.Cup remained in situ and femoral head was explanted.Replaced with synergy, 48 mm head and sleeve.

Manufacturer Narrative

It was reported that patient underwent a revision surgery for left hip due to metal debris, and femoral neck fracture, following a stumble.During the revision the bhr head was removed.The bhr cup remains implanted.As of today, device return and additional information has been requested for this complaint but has not become available.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.The available medical documents were reviewed.According to the provided revision report, the periprosthetic femoral neck fracture occurred while stepping up on a step and stumbled and had immediate pain.Review of the provided implantation and revision report provided no information on potential contributing factor to the fracture.Without x-rays the role of the femoral head position cannot be investigated.Based on the available information the root cause for the revision was an adverse incident due to the patient falling.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: BHR HEMI HEAD 48MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa, CV313 HL; UK CV313HL
• MDR Report Key: 7824794
• MDR Text Key: 118523213
• Report Number: 3005975929-2018-00292
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 00885556071847
• UDI-Public: 00885556071847
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 74123148
• Device Lot Number: 13DW10967
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETABULAR CUP 74122154 LOT 13CW13747
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 45 YR