• 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 HA CTD ACET SHELL 54MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED

  • 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 HA CTD ACET SHELL 54MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED Back to Search Results
Catalog Number 71331954
Device Problem Failure to Align (2522)
Patient Problem Failure of Implant (1924)
Event Date 09/18/2019
Event Type  Injury  
Manufacturer Narrative
Internal reference number: case-(b)(4).
 
Event Description
It was reported that, after tha had been performed on (b)(6) 2018, the patient experienced malalignment of the cup. A revision surgery was performed on (b)(6) 2019 where r3 3 hole ha ctd acet shell 54mm, oxinium fem hd 12/14 32mm +4 and r3 0 degree xlpe lnr 32mm x 54mm were explanted. Patients current health status is unknown. This information was provided by the national joint registry for england, wales, northern ireland and the isle of man supplier feedback; therefore, further information is not available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameR3 3 HOLE HA CTD ACET SHELL 54MM
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
brooks rd. 1450
memphis 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
7000 west william cannon drive
austin
austin, TX 78735
5123913905
MDR Report Key12252151
MDR Text Key264275055
Report Number1020279-2021-06138
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K201701
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 08/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number71331954
Device Lot NumberUNKNOWN
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 Received08/25/2021
Was Device Evaluated by Manufacturer? No
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: 07/30/2021 Patient Sequence Number: 1
Treatment
OXINIUM FEM HD 12/14 32MM +4/UNKNOWN; POLARSTEM STEM STD TI/HA 01 NON-CEM/UNKNOWN; R3 0 DEGREE XLPE LNR 32MM X 54MM/UNKNOWN
-
-