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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CORAIL2 STD SIZE 9 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS INC US CORAIL2 STD SIZE 9 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM Back to Search Results
Catalog Number 3L92509
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Host-Tissue Reaction (1297); Death (1802); Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Discomfort (2330); Not Applicable (3189)
Event Date 02/28/2017
Event Type  Death  
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
Complaint description: patient was revised due to pain and instability. (b)(4) is a reopen of (b)(4) due to receipt of the following information: update apr 17, 2018: pinnacle litigation received. Litigation alleges increasing pain, discomfort, tenderness in the right hip, mental anguish, physical and emotional injury. Patient also experienced stiffness, decreased range of motion, difficulty rotating the hip joint, difficulty weight bearing, difficulty ambulating, elevated metal levels and subsequently died on (b)(6) 2017. Doi: (b)(6) 2009 : dor: (b)(6) 2017 (right hip). Date of death: (b)(6) 2017.
 
Manufacturer Narrative
(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, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Ppf alleges infection, metal wear and metallosis.
 
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Brand NameCORAIL2 STD SIZE 9
Type of DeviceCORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
b.p. 256
warsaw IN 46581 0988
Manufacturer (Section G)
LEEDS MFG & MATERIAL WAREHOUSE
st anthony's road
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6103142063
MDR Report Key7506650
MDR Text Key107990706
Report Number1818910-2018-59389
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number3L92509
Device Lot Number2631650
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/19/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/16/2008
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: 05/11/2018 Patient Sequence Number: 1
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