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, INC. BIOLOX; FEMORAL COMPONENT
  • 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, INC. BIOLOX; FEMORAL COMPONENT Back to Search Results
Catalog Number 76539155
Device Problem Insufficient Information (3190)
Patient Problem No Code Available (3191)
Event Date 01/30/2014
Event Type  Injury  
Event Description
It was reported that revision surgery was performed.
 
Manufacturer Narrative
It is unknown from the information provided if the observed metal transfer and deformation on these components were sustained during removal of the device or were due to impingement of the components in vivo.Bone ingrowth was observed on the acetabular cup.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BIOLOX
Type of Device
FEMORAL COMPONENT
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
melanie travis
1450 brooks road
memphis, TN 38116
9013996233
MDR Report Key3632237
MDR Text Key3986026
Report Number1020279-2014-00101
Device Sequence Number1
Product Code LPF
Combination Product (y/n)N
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 01/30/2014
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 Catalogue Number76539155
Device Lot Number11FT07486
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/30/2014
Initial Date FDA Received02/18/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/22/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age56 YR
-
-