• 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 DELTA CER HEAD 12/14 32MM +5 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

  • 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 DELTA CER HEAD 12/14 32MM +5 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS Back to Search Results
Model Number 1365-32-320
Device Problem Noise, Audible (3273)
Patient Problem No Code Available (3191)
Event Date 04/01/2020
Event Type  Injury  
Manufacturer Narrative

(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

Surgeon is reporting a revision of an unknown pinnacle inlay unknown side because of fracture of inlay. A surgical delay was not reported. Doi: (b)(6) 2017.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDELTA CER HEAD 12/14 32MM +5
Type of DeviceARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key10232861
MDR Text Key197572223
Report Number1818910-2020-14979
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
PMA/PMN NumberK031803
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Type of Report Initial,Followup
Report Date 06/24/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/06/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1365-32-320
Device Catalogue Number136532320
Device LOT Number8437598
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/15/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/28/2016
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: 07/06/2020 Patient Sequence Number: 1
Treatment
APEX HOLE ELIM POSITIVE STOP; CORAIL2 STD SIZE 10; DELTA CER HEAD 12/14 32MM +5; PINN MAR +4 10D 32IDX48OD; PINNACLE 100 ACET CUP 48MM
-
-