Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 NON COL HO SIZE 14; 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 NON COL HO SIZE 14; HIP FEMORAL STEM Back to Search Results
Catalog Number L20314
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problems Erosion (1750); Fever (1858); Foreign Body Reaction (1868); Bone Fracture(s) (1870); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Pocket Erosion (2013); Tissue Damage (2104); Weakness (2145); Discomfort (2330); Injury (2348); Limited Mobility Of The Implanted Joint (2671)
Event Date 11/16/2016
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
On (b)(6) 2017: litigation received.Litigation alleges pain, discomfort, fever, and elevated chromium levels.A temporary cup/ spacer was placed.
 
Manufacturer Narrative
(b)(4).
 
Event Description
In addition to what were previously alleged, pfs alleges that patient needed to use a walker, unable to lift more than (b)(6), bone, tissue and muscle loss.After the review of medical records, it was reported that the patient was revised to address infection.Pain, fever, psoas abscess and collection around the implant were noted.Revision notes reported purulence, erosion, necrotic tissue and fractured anterior cortex.Lab results reported metallosis and inflammatory pseudotumor.
 
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Updated codes for metallosis and pseudotumor.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Udi: (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report. udi: (b)(4).
 
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.H10 additional narrative: added: h6 (device codes).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CORAIL2 NON COL HO SIZE 14
Type of Device
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 Key7044260
MDR Text Key92457785
Report Number1818910-2017-50077
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,health professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/21/2016
Device Catalogue NumberL20314
Device Lot Number2203037
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/26/2017
Initial Date FDA Received11/19/2017
Supplement Dates Manufacturer Received01/30/2018
05/25/2018
03/11/2019
07/22/2019
08/06/2020
Supplement Dates FDA Received02/07/2018
05/29/2018
03/21/2019
07/23/2019
08/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age74 YR
Patient Weight91
-
-