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 ACETLR CUP HAP 48MM W/ IMPTR; ACETABULAR CUP
  • 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 ACETLR CUP HAP 48MM W/ IMPTR; ACETABULAR CUP Back to Search Results
Catalog Number 74120148
Device Problem High Test Results (2457)
Patient Problem Swelling (2091)
Event Type  Injury  
Event Description
It was reported that right hip revision surgery was performed due to elevated test results and fluid accumulation was performed in (b)(6) 2012.
 
Manufacturer Narrative
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ACETLR CUP HAP 48MM W/ IMPTR
Type of Device
ACETABULAR CUP
Manufacturer (Section D)
SMITH & NEPHEW
aurora house
spa park
leamington spa CV31 3HL
UK  CV31 3HL
Manufacturer (Section G)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa 33716
UK   33716
Manufacturer Contact
claudia odoy
schachenallee 29
aarau, FL 5001
SZ   5001
4419264823
MDR Report Key4767779
MDR Text Key5788988
Report Number3005477969-2015-00147
Device Sequence Number1
Product Code NXT
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer,Company Representative,company representati
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/13/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/31/2013
Device Catalogue Number74120148
Device Lot Number094219
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/21/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/13/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
MODULAR SLEEVE, # 74222300, LOT # NI
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age38 YR
-
-