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 MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 4
  • 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 MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 4 Back to Search Results
Catalog Number 01.13.104R
Health Effect - Clinical Code Pain (1994)
Date of Event 07/31/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 august 2018.Lot 176756: 26 items manufactured and released on 18 december 2017.Expiration date: 2022-12-11.No anomalies found related to the problem.To date, 16 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 1 months and half after the primary.The surgeon determined that the femur was fractured.There was no report of trauma.The cause of the fracture is unknown.The surgeon revised the stem, head and liner.The surgery was completed successfully.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 4
Common Device Name
CEMENTLESS ANATOMICAL STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key7832914
Report Number3005180920-2018-00646
Device Sequence Number1908421
Product Code LZO
UDI-Device Identifier07630030803222
UDI-Public07630030803222
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K170845
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/30/2018
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 Date12/18/2017
Device Catalogue Number01.13.104R
Device Lot Number176756
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/31/2018
Initial Report FDA Received Date08/30/2018
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;
-
-