• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK ACETABULAR TRIAL

  • 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
 

DEPUY ORTHOPAEDICS INC US UNK ACETABULAR TRIAL Back to Search Results
Catalog Number UNK ACETABULAR TRIAL
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problems Not Applicable (3189); No Code Available (3191)
Event Date 01/10/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint #: (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported that during the removal of the liner trial the ring and screw attachment portion of the liner trial came disengaged. The liner trial was damaged and a new one needs to be sent to memorial regional. Surgical delay: 5 min.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNK ACETABULAR TRIAL
Type of DeviceUNK ACETABULAR TRIAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key10311389
MDR Text Key200985087
Report Number1818910-2020-16623
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK ACETABULAR TRIAL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/19/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-