Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BIRMINGHAM HIP MODULAR HEAD (BHMH) IMPL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITH & NEPHEW ORTHOPAEDICS LTD BIRMINGHAM HIP MODULAR HEAD (BHMH) IMPL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Catalog Number UNKN01102108
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Metal Related Pathology (4530)
Event Date 11/10/2020
Event Type  Injury  
Manufacturer Narrative
Complaint reference: (b)(4).
 
Event Description
It was reported that the patient underwent revision surgery due to metallosis.
 
Manufacturer Narrative
It was reported that the patient underwent revision surgery due to metallosis.The implanted devices, all of which were used in treatment & additional information has been requested for this complaint but has not become available.No part/lot numbers were provided hence a documentation review could not be completed.If more information is received, this investigation will be reopened.Smith and nephew has not received the device/adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.Without further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BIRMINGHAM HIP MODULAR HEAD (BHMH) IMPL
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house, spa park
leamington spa warwickshire CV31 3HL
UK  CV31 3HL
MDR Report Key10937886
MDR Text Key219310785
Report Number3005975929-2020-00476
Device Sequence Number1
Product Code NXT
Combination Product (y/n)N
PMA/PMN Number
P040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 12/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNKN01102108
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received12/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BHR CUP PART/LOT NUMBER UNKNOWN; MODULAR HEAD SLEEVE PART/LOT NUMBER UNKNOWN; SYNERGY STEM PART/LOT NUMBER UNKNOWN; BHR CUP PART/LOT NUMBER UNKNOWN; MODULAR HEAD SLEEVE PART/LOT NUMBER UNKNOWN; SYNERGY STEM PART/LOT NUMBER UNKNOWN
Patient Outcome(s) Hospitalization; Required Intervention;
-
-