• 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 VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 50/28; DOUBLE MOBILITY LINER

  • 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 VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 50/28; DOUBLE MOBILITY LINER Back to Search Results
Catalog Number 01.26.2850MHC
Device Problem Microbial Contamination of Device (2303)
Patient Problem Unspecified Infection (1930)
Event Date 11/11/2017
Event Type  Injury  
Manufacturer Narrative
Batch review performed on (b)(6) 2017.Versafitcup double mobility hc liner ø 50/28 lot.162319: (b)(4) items manufactured and released on 25 july 2016 expiration date: 2021-06-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with a similar reported event.Cocr ball head 12/14 ø 28 size m 0 (k072857) lot.170152: (b)(4) items manufactured and released on 18 may 2017.Expiration date: 2022-05-03 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 Description
The patient came in due to signs of infection (corynebacterium).The patient was washed out on (b)(6) 2017.No implants were revised.The surgery was completed successfully.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 50/28
Type of Device
DOUBLE MOBILITY LINER
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
Manufacturer (Section G)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ   6874
Manufacturer Contact
stefano baj
strada regina
castel san pietro, 6874
SZ   6874
MDR Report Key7095264
MDR Text Key94131004
Report Number3005180920-2017-00734
Device Sequence Number1
Product Code MEH
UDI-Device Identifier07630030807282
UDI-Public07630030807282
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092265
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other
Type of Report Initial
Report Date 12/07/2017
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
Device Operator Health Professional
Device Expiration Date06/27/2021
Device Catalogue Number01.26.2850MHC
Device Lot Number162319
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/10/2017
Initial Date FDA Received12/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/25/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-