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 IRELAND 9616671 CORAIL2 STD SIZE 13; 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 IRELAND 9616671 CORAIL2 STD SIZE 13; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM Back to Search Results
Model Number 3L92513
Health Effect - Clinical Code Pain (1994)
Date of Event 10/17/2019
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
Asr revision.Asr xl: right hip.Reason for revision: pain.Doi: (b)(6) 2009; dor: (b)(6) 2019: right hip.
 
Additional 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CORAIL2 STD SIZE 13
Common Device Name
CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI 
MDR Report Key11177081
Report Number1818910-2021-01222
Device Sequence Number11320536
Product Code LZO
UDI-Device Identifier10603295168799
UDI-Public10603295168799
Combination Product (Y/N)N
Initial Reporter CountryRS
PMA/510(K) Number
K190344
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2009
Device Explanted Year2019
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 12/23/2020
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
Operator of Device Health Professional
Device Model Number3L92513
Device Catalogue Number3L92513
Device Lot Number5011823
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 12/23/2020
Supplement Date Received by Manufacturer02/24/2021
Initial Report FDA Received Date01/15/2021
Supplement Report FDA Received Date02/25/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
ASR ACETABULAR IMPLANT 54; DEPUY ASR XL FEM IMP SIZE 47; TAPER SLEEVE ADAPTER 12/14 +2; ASR ACETABULAR IMPLANT 54; DEPUY ASR XL FEM IMP SIZE 47; TAPER SLEEVE ADAPTER 12/14 +2
Outcome Attributed to Adverse Event Required Intervention;
-
-