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

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK HIP FEMORAL STEM CORAIL

  • 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 IRELAND - 9616671 UNK HIP FEMORAL STEM CORAIL Back to Search Results
Catalog Number UNK HIP FEMORAL STEM CORAIL
Device Problem Loss of Osseointegration (2408)
Patient Problems Inadequate Osseointegration (2646); No Code Available (3191)
Event Date 10/19/2020
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
It was reported that the patient had previous surgery in 2008 and no records could be found. Patient had loosening of the corail stem at bone to implant interface. It was removed along with the 36x54 pinnacle metal liner and 36 metal head. A new 36x54 neutral poly was placed and surgeon replaced the stem with a biomet. Doi: 2008, dor: (b)(6) 2020, unknown hip.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNK HIP FEMORAL STEM CORAIL
Type of DeviceFEMORAL STEM
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key10786953
MDR Text Key214616211
Report Number1818910-2020-23935
Device Sequence Number1
Product Code KWY
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 10/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP FEMORAL STEM CORAIL
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 Received12/01/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/04/2020 Patient Sequence Number: 1
Treatment
(36 METAL HEAD); (PINNACLE 36X54 METAL LINER)
-
-