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 TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/14 MM R
  • 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 TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/14 MM R Back to Search Results
Catalog Number 02.12.0514FR
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 12/22/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 january 2018 lot 152458: (b)(4) items manufactured and released on 10 nov 2015.Expiration date: 2020-10-19 no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
One year and 1 month after primary the patient came in complaining of instability.The cause of the instability is unknown.No trauma reported.The surgeon revised successfully a 14mm poly for a 17mm.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/14 MM R
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key7206144
Report Number3005180920-2017-00863
Device Sequence Number10992161
Product Code JWH
UDI-Device Identifier07630030826825
UDI-Public07630030826825
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K121416
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/19/2018
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 Date10/19/2020
Device Catalogue Number02.12.0514FR
Device Lot Number152458
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/22/2017
Initial Report FDA Received Date01/19/2018
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;
-
-