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

Catalog Number 74120154

Device Problems Metal Shedding Debris (1804); Insufficient Information (3190)

Patient Problems Injury (2348); Reaction (2414); No Code Available (3191)

Event Date 03/30/2017

Event Type  Injury  

Event Description

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

Manufacturer Narrative

As of today, device return and additional information has been requested for this complaint but has not become available.Since no device part & lot details were received for investigation, no thorough manufacturing record review can be performed.The provided medical documents have been reviewed.This complaint is from the bhmh modular hip ous study reporting adverse event 1 for subject (b)(6).Adverse event 1 is "armed involves operative site hip, moderate severity, treated with invasive or surgical procedure, right hip revision surgery performed with removal of the acetabular cup and taper sleeve.No metal ion levels have been submitted.Several attempts have been made to obtain clinical/medical documents to no avail.Without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.If the products or additional information become available in the future, this case will be reopened.Without additional information about this patient's particular case, our investigation remains inconclusive.No preventative or corrective action has been initiated as a result of this investigation.

• 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: 7650285
• MDR Text Key: 112723516
• Report Number: 3005975929-2018-00240
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502582
• UDI-Public: 03596010502582
• 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: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74120154
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/27/2018
• Patient Sequence Number: 1
• Treatment: FEMORAL STEM, # 71306614, LOT # UNKNOWN; MODULAR HEAD, # 74222148, LOT # UNKNOWN; MODULAR SLEEVE, # 74222300, LOT # UNKNOWN; FEMORAL STEM, # 71306614, LOT # UNKNOWN; MODULAR HEAD, # 74222148, LOT # UNKNOWN; MODULAR SLEEVE, # 74222300, LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 110