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; HIP CUP
  • 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; HIP CUP Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 12/13/2023
Event Type  Injury  
Manufacturer Narrative
No analysis could be performed since lot numbers are unknown and devices are not available for inspection.
 
Event Description
The patient had a primary hip surgery in the united kingdom on an unknown date.Presently, the patient came in reporting pain due to a loose cup.The surgeon revised the cup, screws, liner and head and the surgery was completed successfully.No other info are available at the moment.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of Device
HIP CUP
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
Manufacturer (Section G)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ   6874
Manufacturer Contact
marco giannessi
strada regina
castel san pietro, switzerland 6874
SZ   6874
MDR Report Key18501916
MDR Text Key332762842
Report Number3005180920-2023-01071
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received12/13/2023
Was Device Evaluated by Manufacturer? No
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;
Patient SexFemale
-
-