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 COLLARED HA COATED STD STEM SIZE 2; 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 STEM COLLARED HA COATED STD STEM SIZE 2; CEMENTLESS HIP STEM Back to Search Results
Catalog Number 01.18.232
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 08/13/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 september 2018.Lot 132994: (b)(4) items manufactured and released on 02 september 2013.Expiration date: 2018-07-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
About 4 years and a half after primary, the surgeon revised the patient for stem potting.Stem, head and liner swap performed successfully.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
STEM COLLARED HA COATED STD STEM SIZE 2
Common Device Name
CEMENTLESS HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key7868587
Report Number3005180920-2018-00670
Device Sequence Number13878760
Product Code LZO
UDI-Device Identifier07630030804571
UDI-Public07630030804571
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K121011
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 09/12/2018
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 Date07/31/2018
Device Catalogue Number01.18.232
Device Lot Number132994
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/13/2018
Initial Report FDA Received Date09/12/2018
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 Age73 YR
-
-