• 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. 1818910 TAPERED SPACER ARTICUL/EZE -3 HIP OTHER IMPLANT

  • 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. 1818910 TAPERED SPACER ARTICUL/EZE -3 HIP OTHER IMPLANT Back to Search Results
Catalog Number 136308000
Device Problem Insufficient Information (3190)
Patient Problem Pain (1994)
Event Date 08/18/2017
Event Type  Injury  
Manufacturer Narrative
No device associated with this report was received for examination. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Patient was revised to address painful hemi hip. Converted to total hip.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTAPERED SPACER ARTICUL/EZE -3
Type of DeviceHIP OTHER IMPLANT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46581
5743725905
MDR Report Key6941788
MDR Text Key105696330
Report Number1818910-2017-26372
Device Sequence Number1
Product Code LZY
UDI-Device Identifier10603295032663
UDI-Public10603295032663
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K903084
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number136308000
Device Lot NumberH34559
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 Received11/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/20/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/11/2017 Patient Sequence Number: 1
-
-