• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE FEM KNEE W/EPI L STD PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/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
 

STANMORE IMPLANTS WORLDWIDE FEM KNEE W/EPI L STD PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number MKFE-LSTD
Device Problems Packaging Problem (3007); Insufficient Information (3190)
Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
Event Date 06/30/2020
Event Type  malfunction  
Manufacturer Narrative
An investigation is being performed in an attempt to identify the cause of the event. Should additional information become available it will be reported in a supplemental report.
 
Event Description
Opened sealed implant box to find (b)(6) had cut open and taped up the sterile implant. 5 min surgical delay.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFEM KNEE W/EPI L STD
Type of DevicePROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
STANMORE IMPLANTS WORLDWIDE
210 centennial avenue
centennial park, elstree
borehamwood WD6 3 SJ
UK WD6 3SJ
Manufacturer (Section G)
STANMORE IMPLANTS WORLDWIDE
210 centennial avenue
centennial park, elstree
borehamwood WD6 3 SJ
UK WD6 3SJ
Manufacturer Contact
diana rogers
210 centennial avenue
centennial park, elstree
borehamwood WD6 3-SJ
UK   WD6 3SJ
2082386500
MDR Report Key10312231
MDR Text Key199999267
Report Number3004105610-2020-00122
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
K121029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberMKFE-LSTD
Device Lot NumberA26504
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/06/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/28/2020
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: 07/23/2020 Patient Sequence Number: 1
-
-