• 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 3 HOLE ACET SHELL 50MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

  • 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 3 HOLE ACET SHELL 50MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Catalog Number 71335550
Device Problem Unintended Movement (3026)
Patient Problem Joint Dislocation (2374)
Event Date 06/18/2020
Event Type  Injury  
Event Description
It was reported that patient had smith+nephew components since (b)(6) 2018. Revision surgery was performed on (b)(6) 2020 due to loosening of the left hip prosthesis.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameR3 3 HOLE ACET SHELL 50MM
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
sarah freestone
1450 brooks road
memphis, TN 38116
0447940038
MDR Report Key10359591
MDR Text Key201496644
Report Number1020279-2020-03660
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K070756
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 11/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71335550
Device Lot Number17MM06792
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/20/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/11/2017
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: 08/03/2020 Patient Sequence Number: 1
-
-