• 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 10 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 10 HIP FEMORAL STEM Back to Search Results
Catalog Number L20310
Device Problems Loose or Intermittent Connection (1371); Loss of Osseointegration (2408)
Patient Problems Host-Tissue Reaction (1297); Pain (1994); Loss of Range of Motion (2032); Scarring (2061); Tissue Damage (2104); Anxiety (2328); Distress (2329); Injury (2348); Depression (2361); Osteolysis (2377); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); Not Applicable (3189); No Code Available (3191)
Event Date 12/06/2017
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 defective implant resulting to damage to patient¿s hip joint and body, pain and emotional distress. Doi: (b)(6) 2006; dor: not reported; right hip.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Ppf alleges loosening of stem, metal wear, metallosis, and elevated metal ions.
 
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 will be filed as appropriate.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCORAIL2 NON COL HO SIZE 10
Type of DeviceHIP FEMORAL STEM
Manufacturer (Section D)
DEPUY FRANCE SAS 3003895575
7 allée irène joliot curie
bp 256
saint priest cedex 69801
FR 69801
Manufacturer (Section G)
DEPUY INTERNATIONAL LTD. 8010379
st. anthony's rd
b.p. 256
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, IN 19380-0988
6103142063
MDR Report Key7595698
MDR Text Key110863600
Report Number1818910-2018-61997
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042992
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 05/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberL20310
Device Lot Number2229001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/25/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/24/2006
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: 06/13/2018 Patient Sequence Number: 1
-
-