• 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. GII SLT 3 MOD TIB CUTBLCK LT PRSTHSIS,KNEE,PATLLO/FMRTIBL,SMI-CNSTRND,UNCMNTD,PORS,COATD,POLYMR/MTAL/POLYMR

  • 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. GII SLT 3 MOD TIB CUTBLCK LT PRSTHSIS,KNEE,PATLLO/FMRTIBL,SMI-CNSTRND,UNCMNTD,PORS,COATD,POLYMR/MTAL/POLYMR Back to Search Results
Catalog Number 71440209
Device Problem Difficult To Position (1467)
Patient Problem Injury (2348)
Event Date 03/23/2018
Event Type  Injury  
Event Description

It was reported that during surgery is difficult to fix tibial cutting block in correct position, so the surgeon had to proceed with a recut.

 
Manufacturer Narrative

The associated complaint device was not returned. The clinical/medical team concluded, it was reported that the surgeon fixed the block/kept it in the correct position and completed the procedure with a 3 to 5 minute surgical delay. The patient impact beyond the reported minimal surgical delay cannot be determined. No further medical assessment is warranted at this time. We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary. Without the actual product involved, our investigation cannot proceed. If the device or new information is received in the future, this complaint can be re-opened.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGII SLT 3 MOD TIB CUTBLCK LT
Type of DevicePRSTHSIS,KNEE,PATLLO/FMRTIBL,SMI-CNSTRND,UNCMNTD,PORS,COATD,POLYMR/MTAL/POLYMR
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
sarah freestone
1450 brooks road
memphis, TN 38116
MDR Report Key7489671
MDR Text Key107434678
Report Number1020279-2018-00883
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
PMA/PMN NumberK121393
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Type of Report Initial,Followup
Report Date 06/26/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/07/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number71440209
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2018
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 05/07/2018 Patient Sequence Number: 1
-
-