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 H HA COATED STD STEM SIZE 0; HIP 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 H HA COATED STD STEM SIZE 0; HIP CEMENTLESS STEM Back to Search Results
Model Number 01.18.130
Health Effect - Clinical Code Pain (1994)
Date of Event 01/09/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on xx january 2020: lot 111243: (b)(4) items manufactured and released on 25-may-2011.Expiration date: 2016-04-30.No anomalies found related to the problem.To date, all the items of the same lot have been already sold without any similar reported event since 1-1-2016.
 
Event or Problem Description
About 6 years and a half after primary revision surgery for pain and radiolucency at stem level.Stem, head and liner revised successfully.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
STEM: AMISTEM H HA COATED STD STEM SIZE 0
Common Device Name
HIP CEMENTLESS STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9646942
Report Number3005180920-2020-00013
Device Sequence Number401130
Product Code LZO
UDI-Device Identifier07630030804069
UDI-Public07630030804069
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K093944
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 01/30/2020
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 Date04/30/2016
Device Model Number01.18.130
Device Catalogue Number01.18.130
Device Lot Number111243
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/06/2020
Initial Report FDA Received Date01/30/2020
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;
-
-