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 DOUBLE MOBILITY HC LINER Ø 64/28
  • 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 DOUBLE MOBILITY HC LINER Ø 64/28 Back to Search Results
Catalog Number 01.26.2864MHC
Health Effect - Clinical Code Pain (1994)
Date of Event 03/14/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 april 2018; lot 153661: (b)(4) items manufactured and released on 29 october 2015.Expiration date: 2020-10-10; 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.The cause of pain is unknown.The surgeon revised the liner.The surgery was completed successfully.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DOUBLE MOBILITY HC LINER Ø 64/28
Common Device Name
DOUBLE MOBILITY HC LINER
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key7425012
Report Number3005180920-2018-00227
Device Sequence Number16169774
Product Code MEH
UDI-Device Identifier07630030807534
UDI-Public07630030807534
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K092265
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/12/2018
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 Date10/10/2020
Device Catalogue Number01.26.2864MHC
Device Lot Number153661
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 03/14/2018
Initial Report FDA Received Date04/12/2018
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;
Patient Weight109
-
-