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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 NON COL HO SIZE 14 HIP FEMORAL STEM

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DEPUY FRANCE SAS - 3003895575 CORAIL2 NON COL HO SIZE 14 HIP FEMORAL STEM Back to Search Results
Model Number L20314
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); No Code Available (3191)
Event Date 01/27/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Initial reporter 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
Pcf and medical records received. After review of medical records, patient was revised to addressed painful left metal on metal hip replacement and limping more. Operatives notes indicated copious amount of thick dark fluid extruded from the joint consistent with severe metallosis of the hip. There is a dead tissue around posterior and anterior portion. Exposed the femoral stem, there was some erosion of the bone around the proximal portion of the stem, there is no evidence of loosening and no impingement in the hip and found to be stable. Doi: (b)(6) 2006; dor: (b)(6) 2017; left hip.
 
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Brand NameCORAIL2 NON COL HO SIZE 14
Type of DeviceHIP 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 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, PA 19380-0988
6107428552
MDR Report Key9653021
MDR Text Key177376590
Report Number1818910-2020-03692
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberL20314
Device Catalogue NumberL20314
Device Lot Number1933545
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 Received03/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 01/31/2020 Patient Sequence Number: 1
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