• 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 AMISTEM C CEMENTED STD STEM #3 CEMENTED FEMORAL 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 AMISTEM C CEMENTED STD STEM #3 CEMENTED FEMORAL STEM Back to Search Results
Catalog Number
Device Problem Device Operates Differently Than Expected
Event Type  Injury  
Event Description

(b)(4).

 
Manufacturer Narrative

Batch review performed on july 31, 2015. Lot 140787: (b)(4) stems manufactured and released on april 7, 2014. No anomalies found. To date, (b)(4) items of the lot have been already sold without any similar issue reported. Clinical eval performed on july 24,2015 by (b)(4). The stem appears to be embedded in an uneven cement mantle. Cement is remarkably deficient on anterior/proximal and distal portion of the stem. In these conditions, sinking of the stem is a possible complication. We have no info as to the possible cause of suboptimal cementation, which appears to be the root cause for revision. On july 14, 2015, the sales reported that the pieces will not available for further investigation.

 
Manufacturer Narrative

On 05 october 2015 it was prepared a final report with the information already submitted in the initial report. On 07 october 2015 the report was sent to the initial reporter and the case was closed.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAMISTEM C CEMENTED STD STEM #3
Type of DeviceCEMENTED FEMORAL STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL, SA
castel san pietro
SZ 
Manufacturer (Section G)
MEDACTA INTERNATIONAL, SA
strada regina 6874
castel san pietro
SZ 
Manufacturer Contact
erin baumstark
 
3128782381
MDR Report Key4963986
Report Number3005180920-2015-00166
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation NOT APPLICABLE
Type of Report Initial,Followup
Report Date 11/04/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/31/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number
Device LOT Number
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-