• 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 11 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 11 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM Back to Search Results
Model Number 3L92511
Device Problem Loss of Osseointegration (2408)
Patient Problems Muscular Rigidity (1968); Pain (1994); Renal Failure (2041); Weakness (2145); Anxiety (2328); Discomfort (2330); Depression (2361); Osteolysis (2377); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Event Date 03/01/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Occupation: lawyer. 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 and medical records received. Litigation alleges pain, discomfort, weakness, limited adl, stress, anxiety, depression, insomia and ckd stage 3. After review of medical records the patient was revised to address pain and osteolysis. Mri confirm presence of ostial lysis around femur but no loosening. Clinical visit reported tenderness over greater trochanter, discomfort, instability, stiffness, difficulty adl, metalic streak artifact obscure the tendons, some cortical hypertrophy at the tip of the stem but no loosening. Doi: (b)(6) 2007; dor: (b)(6) 2018; right hip.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCORAIL2 STD SIZE 11
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 69801
FR 69801
Manufacturer (Section G)
LEEDS MFG & MATERIAL WAREHOUSE
st anthonys road
leeds LS11 8DT
EI LS11 8DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key10143911
MDR Text Key194825064
Report Number1818910-2020-13649
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,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3L92511
Device Catalogue Number3L92511
Device Lot Number2262937
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 Received07/26/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/11/2007
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: 06/11/2020 Patient Sequence Number: 1
Treatment
ARTICULEZE M HEAD 36MM -2; CORAIL2 STD SIZE 11; PINNACLE 100 ACET CUP 52MM; PINNACLE MTL INS NEUT36IDX52OD
-
-