• 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 UNIPOLAR 46MM PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL

  • 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 UNIPOLAR 46MM PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL Back to Search Results
Model Number 71326600
Device Problem Material Deformation (2976)
Patient Problem Injury (2348)
Event Date 08/14/2019
Event Type  Injury  
Event Description
It was reported that a revision surgery was performed due to a dislocation. The acetabulum had a significant deformity in the anterior part and it was changed to gain stability of the joint.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTANDEM UNIPOLAR 46MM
Type of DevicePROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL
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
memphis, TN 38116
0447940038
MDR Report Key8981054
MDR Text Key157094556
Report Number1020279-2019-03323
Device Sequence Number1
Product Code LZY
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K896580
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number71326600
Device Catalogue Number126646
Device Lot Number15HM17733
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/26/2015
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: 09/10/2019 Patient Sequence Number: 1
Treatment
PART NUMBER 71303200 / LOT NUMBER 19CM09046; PART NUMBER 71332520 / LOT NUMBER 18MM01397; PART NUMBER 71332525 / LOT NUMBER 18LM20371; PART NUMBER 71332530 / LOT NUMBER 19DB00024; PART NUMBER 71337648 / LOT NUMBER 18AM02010
-
-