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. OXINIUM FEM HD 12/14 32MM +8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
  • 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. OXINIUM FEM HD 12/14 32MM +8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER Back to Search Results
Catalog Number 71343208
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code Joint Dislocation (2374)
Date of Event 07/02/2014
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported the patient presented with a preoperative diagnosis of alignment disassociation of the right hip.The patient underwent a right hip revision.
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see attached for the results of our investigation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
OXINIUM FEM HD 12/14 32MM +8
Common Device Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6742417
Report Number1020279-2017-00559
Device Sequence Number13646080
Product Code LZO
UDI-Device Identifier03596010474230
UDI-Public03596010474230
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K021673
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2014
Reporter Type Manufacturer
Report Source company representative,consum
Initial Reporter Occupation Attorney
Type of Report Initial,Followup
Report Date (Section B) 10/02/2017
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 Expiration Date06/13/2022
Device Catalogue Number71343208
Device Lot Number12FM10062
Initial Date Received by Manufacturer 06/28/2017
Supplement Date Received by Manufacturer06/28/2017
Initial Report FDA Received Date07/25/2017
Supplement Report FDA Received Date10/02/2017
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 Hospitalization; Required Intervention;
Patient Age54 YR
-
-