• 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 BHR ACETABULAR CUP 50MM 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 BHR ACETABULAR CUP 50MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Catalog Number 74120150
Device Problems Device Slipped (1584); Insufficient Information (3190)
Patient Problems Failure of Implant (1924); Toxicity (2333)
Event Date 04/12/2017
Event Type  Injury  
Event Description

Left hip revision surgery was performed due to elevated levels of cobalt and chromium, pseudotumour, plus aseptic loosening of acetabular components.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBHR ACETABULAR CUP 50MM
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora housa
spa park
leamington spa CV313 HL
UK CV313HL
Manufacturer (Section G)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa
Manufacturer Contact
sarah freestone
MDR Report Key8063148
MDR Text Key126917229
Report Number3005975929-2018-00437
Device Sequence Number1
Product Code NXT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/17/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/13/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2013
Device Catalogue Number74120150
Device LOT Number090203
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/01/2018
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/13/2018 Patient Sequence Number: 1
Treatment
71356006 FEMORAL STEM 08CM17522; 74122542 HEMI HEAD 08CW16083; 74222200 MODULAR SLEEVE 08BW15652
-
-