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: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/10MM; KNEE FIXED TIBIAL INSERT
  • 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
 

MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/10MM; KNEE FIXED TIBIAL INSERT Back to Search Results
Model Number 02.07.0410SCF
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 02/06/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 february 2020: lot 185114: (b)(4) items manufactured and released on 20-sept-2018.Expiration date: 2023-08-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar event reported.
 
Event or Problem Description
Revision surgery performed about 2 months after primary surgery, for knee infection.I&d and liner swap performed successfully.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/10MM
Common Device Name
KNEE FIXED TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9785455
Report Number3005180920-2020-00113
Device Sequence Number2573960
Product Code JWH
UDI-Device Identifier07630030817656
UDI-Public07630030817656
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K103170
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 03/04/2020
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 Date08/30/2023
Device Model Number02.07.0410SCF
Device Catalogue Number02.07.0410SCF
Device Lot Number185114
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/03/2020
Initial Report FDA Received Date03/04/2020
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 Required Intervention;
-
-