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 ORTHOPAEDICS LTD BHR MODULAR HEAD 46MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR 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 ORTHOPAEDICS LTD BHR MODULAR HEAD 46MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED Back to Search Results
Catalog Number 74222146
Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/29/2019
Event Type  Injury  
Event Description
Left hip revision surgery was performed.
 
Manufacturer Narrative
Smith & nephew is submitting this report pursuant to the provisions of 21cfr, part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.- attachment: [233084 summary.Pdf].
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BHR MODULAR HEAD 46MM
Type of Device
PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa CV31 3HL
UK  CV31 3HL
MDR Report Key8589831
MDR Text Key144385277
Report Number3005975929-2019-00197
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
PMA/PMN Number
P040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number74222146
Was Device Available for Evaluation? No
Date Manufacturer Received05/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MODULAR SLEEVE, # 74222100, LOTT # UNKNOWN; MODULAR SLEEVE, # 74222100, LOTT # UNKNOWN
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age72 YR
-
-