• 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 ACETABULAR CUP HAP SIZE 48/54 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 ACETABULAR CUP HAP SIZE 48/54 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Catalog Number 74122154
Device Problems Device Slipped (1584); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Tissue Damage (2104); Toxicity (2333); Injury (2348); Reaction (2414)
Event Date 11/01/2018
Event Type  Injury  
Event Description

It was reported that left hip revision surgery was performed due to metallosis, elevated blood levels of chromium and cobalt; hyperplasia, chronic hip joint inflammation, cloudy fluid accumulation around hip joint, adverse local tissue reaction, sinus tract formation, metal debris into the pelvis, soft tissue damage, loosening of the implant and failed left hip arthroplasty.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameACETABULAR CUP HAP SIZE 48/54
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa CV31 3HL
UK CV31 3HL
Manufacturer (Section G)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa CV31 3HL
UK CV31 3HL
Manufacturer Contact
sarah freestone
0447940038
MDR Report Key8575820
MDR Text Key143931016
Report Number3005975929-2019-00190
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 CONSUMER,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/14/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/02/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2016
Device Catalogue Number74122154
Device LOT Number11HW33928
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/07/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/15/2011
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: 05/02/2019 Patient Sequence Number: 1
-
-