• 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. TANDEM INTL BIPOLAR 47OD 28ID PROSTHESIS, HIP, HEMI-, FMRL,MTL/POLYMER,CMNTD OR UNEMNTD

  • 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. TANDEM INTL BIPOLAR 47OD 28ID PROSTHESIS, HIP, HEMI-, FMRL,MTL/POLYMER,CMNTD OR UNEMNTD Back to Search Results
Model Number 71324047
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Injury (2348)
Event Date 02/18/2020
Event Type  Injury  
Event Description
It was reported that the patient had s&n components since the unknown date and revision surgery was performed due to infection. Tandem intl bipolar 47od 28id was explanted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTANDEM INTL BIPOLAR 47OD 28ID
Type of DevicePROSTHESIS, HIP, HEMI-, FMRL,MTL/POLYMER,CMNTD OR UNEMNTD
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
sarah freestone
1450 brooks road
MDR Report Key9779247
MDR Text Key181729327
Report Number1020279-2020-00760
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K023743
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number71324047
Device Catalogue Number71324047
Device Lot Number15EM09316
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/21/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/13/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/03/2020 Patient Sequence Number: 1
-
-