Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 20 DEG XLPE ACET LNR 32MM X 52MM; 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 20 DEG XLPE ACET LNR 32MM X 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Catalog Number 71337652
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 12/18/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a surgical intervention was performed due to instability.The liner and the head were removed.
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see the attached file for the results of our investigation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
R3 20 DEG XLPE ACET LNR 32MM X 52MM
Common Device Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7171655
Report Number1020279-2018-00031
Device Sequence Number16483071
Product Code MBL
UDI-Device Identifier03596010598493
UDI-Public03596010598493
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K070756
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 03/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Catalogue Number71337652
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 12/18/2017
Supplement Date Received by Manufacturer12/18/2017
Initial Report FDA Received Date01/08/2018
Supplement Report FDA Received Date03/01/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other; Required Intervention;
-
-