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

MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 STD SIZE 10 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

  • 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 FRANCE SAS - 3003895575 CORAIL2 STD SIZE 10 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM Back to Search Results
Catalog Number 3L92510
Device Problems Loose or Intermittent Connection (1371); Osseointegration Problem (3003); Insufficient Information (3190)
Patient Problems Foreign Body Reaction (1868); Pain (1994); Anxiety (2328); Distress (2329); Injury (2348); Depression (2361); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671); Not Applicable (3189); No Code Available (3191)
Event Type  Injury  
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
Pinnacle litigation received. Litigation alleges pain, metallosis, metal poisoning, lack of mobility, injury and disability, emotional distress, anxiety, depression, and a feeling looseness in her left hip. Doi: (b)(6) 2008; dor: not revised; left hip.
 
Manufacturer Narrative
Product complaint # (b)(4). Investigation summary: no device associated with this report was received for examination. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. Device history lot: null. Device history batch: null. Device history review: null. If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Updated patient harm. Doi: (b)(6) 2008 - dor: none reported (left hip).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCORAIL2 STD SIZE 10
Type of DeviceCORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY FRANCE SAS - 3003895575
7 allee irene joliot-curie
b.p. 256
saint priest cedex IN 69801
FR 69801
MDR Report Key7510404
MDR Text Key108108335
Report Number1818910-2018-59503
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
K042992
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 09/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2011
Device Catalogue Number3L92510
Device Lot Number2321903
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/03/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/14/2018 Patient Sequence Number: 1
-
-