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 STEM: AMISTEM COLLARED STEM COLLARED HA COATED STD STEM SIZE 3; CEMENTLESS STEM
  • 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 STEM: AMISTEM COLLARED STEM COLLARED HA COATED STD STEM SIZE 3; CEMENTLESS STEM Back to Search Results
Model Number 01.18.233
Medical Device Problem Code Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 06/15/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 june 2020: lot 180040: (b)(4) items manufactured and released on 30-may-2018.Expiration date: 2023-05-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event.
 
Event or Problem Description
Revision surgery performed 1 year and 10 months after primary surgery for stem loosening.The surgery was completed successfully.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
STEM: AMISTEM COLLARED STEM COLLARED HA COATED STD STEM SIZE 3
Common Device Name
CEMENTLESS STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key10239483
Report Number3005180920-2020-00387
Device Sequence Number2603542
Product Code LZO
UDI-Device Identifier07630030804588
UDI-Public07630030804588
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K121011
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2020
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/07/2020
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 Date05/21/2023
Device Model Number01.18.233
Device Catalogue Number01.18.233
Device Lot Number180040
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/08/2020
Initial Report FDA Received Date07/07/2020
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;
-
-