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 QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 0, SHORT NECK; CEMENTLESS HIP 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 QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 0, SHORT NECK; CEMENTLESS HIP STEM Back to Search Results
Catalog Number 01.12.20SN
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/22/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 september 2018; lot 177568: (b)(4) items manufactured and released on 29 march 2018.Expiration date: 2023-03-20; 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
The patient came in complaining of pain few days after primary surgery.The surgeon determined that the patient had fractured the femur.The cause of the fracture is unknown.No trauma was reported.The surgeon successfully revised the stem, head and liner.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 0, SHORT NECK
Common Device Name
CEMENTLESS HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key7897537
Report Number3005180920-2018-00708
Device Sequence Number18861703
Product Code JDI
UDI-Device Identifier07630030802607
UDI-Public07630030802607
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K082792
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 09/21/2018
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 Date03/20/2023
Device Catalogue Number01.12.20SN
Device Lot Number177568
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/22/2018
Initial Report FDA Received Date09/21/2018
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;
-
-