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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

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DEPUY FRANCE SAS - 3003895575 CORAIL2 STD SIZE 10 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM Back to Search Results
Catalog Number 3L92510
Device Problem Noise, Audible (3273)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Test Result (2695)
Event Date 01/01/2017
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
It was reported that the patient have been facing inconvenience pain in the hip area, too much of joint noise and other issues. Also experiencing loud and continuous cracking noise with every movement and leading to limping. This is affecting by daily routine, hampering the patient's work and mental peace. The patient is scared and concerned with the rate of increase in metal levels in blood.
 
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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 69801
FR 69801
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key9526034
MDR Text Key185718555
Report Number1818910-2019-124794
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 company representative,foreig
Type of Report Initial
Report Date 12/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number3L92510
Device Lot Number2343755
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/17/2007
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: 12/27/2019 Patient Sequence Number: 1
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