• 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. R3 ACETABULAR SHELL 54MM PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL CEMENTED ACETABULAR 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. R3 ACETABULAR SHELL 54MM PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL CEMENTED ACETABULAR COMPONENT) Back to Search Results
Catalog Number 71334154
Device Problem Loose or Intermittent Connection (1371)
Patient Problem Injury (2348)
Event Date 09/13/2019
Event Type  Injury  
Event Description
It was reported that a revision surgery was planned due to significant osteolysis up on the trochanter major.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameR3 ACETABULAR SHELL 54MM
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED (METAL CEMENTED ACETABULAR 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
sarah freestone
1450 brooks road
memphis, TN 
0447940038
MDR Report Key9182939
MDR Text Key162441629
Report Number1020279-2019-03623
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 02/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71334154
Device Lot Number10DM08672
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 Received02/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/11/2019 Patient Sequence Number: 1
-
-