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 SL-PLUS; SL-PLUS STEM LATERAL 3 NON-CEMENTED
  • 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 SL-PLUS; SL-PLUS STEM LATERAL 3 NON-CEMENTED Back to Search Results
Catalog Number 75002751
Device Problem Device Slipped (1584)
Patient Problem No Code Available (3191)
Event Type  Injury  
Event Description
It was reported that a revision surgery was performed due to suspected loosening of the device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SL-PLUS
Type of Device
SL-PLUS STEM LATERAL 3 NON-CEMENTED
Manufacturer (Section D)
SMITH&NEPHEW
schachenallee 29
aarau CH50 00
SZ  CH5000
Manufacturer (Section G)
SMITH&NEPHEW, INC
schachenallee 29
aarau CH50 00
SZ   CH5000
Manufacturer Contact
phillip emmert
1450 e. brooks rd
memphis, TN 38116
9013995296
MDR Report Key3796385
MDR Text Key4364797
Report Number9613369-2014-00066
Device Sequence Number1
Product Code JDG
Combination Product (y/n)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/28/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/16/2011
Device Catalogue Number75002751
Device Lot Number0411.13.6307
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/06/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/15/2014
Initial Date FDA Received05/07/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/28/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/17/2004
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
75004170- CERAMIC BALL HEAD 28M - (B)(4)
Patient Outcome(s) Hospitalization; Required Intervention;
-
-