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 TERMINAL CUP IMPACTOR FOR METAL BACK CC; SURGICAL INSTRUMENT FOR HIP
  • 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 TERMINAL CUP IMPACTOR FOR METAL BACK CC; SURGICAL INSTRUMENT FOR HIP Back to Search Results
Catalog Number 01.15.10.0261
Device Problem Disconnection (1171)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/10/2015
Event Type  malfunction  
Event Description
It was not possible to disconnect the terminal cc from the trio cup.The surgeon used a second trio cup implanted with the cup impactor to complete the surgery.The cup impactor was correctly connected with the implant.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TERMINAL CUP IMPACTOR FOR METAL BACK CC
Type of Device
SURGICAL INSTRUMENT FOR HIP
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
castel san pietro
SZ 
Manufacturer (Section G)
MEDACTA USA INC.
1556 w carroll ave
chicago IL 60607 000
Manufacturer Contact
1556 w carroll ave
chicago, IL 60607-0000
MDR Report Key4908887
MDR Text Key19983720
Report Number3006639916-2015-00140
Device Sequence Number1
Product Code LXH
Combination Product (y/n)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 07/09/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number01.15.10.0261
Device Lot Number1413789
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/09/2015
Distributor Facility Aware Date07/09/2015
Device Age6 MO
Event Location Hospital
Date Report to Manufacturer07/09/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/09/2015
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
48 (K122911): CODE 01.26.45.1152, LOT #150076; VERSAFITCUP CC TRIO NO HOLES ACETABULAR SHELL -
Patient Outcome(s) Other;
-
-