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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 12 HIP FEMORAL STEM

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DEPUY FRANCE SAS - 3003895575 CORAIL2 NON COL HO SIZE 12 HIP FEMORAL STEM Back to Search Results
Model Number L20312
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Sepsis (2067); No Code Available (3191)
Event Date 02/17/2020
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
Clinical adverse event received for hematogenous seeding of his right hip: infection deep; had a gangrenous gallbladder which seeded his hip event is serious and is considered moderate event is definitely related to device and is definitely not related to procedure. Date of implantation: (b)(6) 2020. Date of event (onset): (b)(6) 2020. (right hip). Treatment: surgical irrigation & debridement, without revision of head and liner; medication: oral ancef 1 gm tid.
 
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Brand NameCORAIL2 NON COL HO SIZE 12
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 FRANCE SAS 3003895575
7 allee irene joliot-curie
b.p. 256
saint priest cedex 69801
FR 69801
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key9847955
MDR Text Key190353169
Report Number1818910-2020-08432
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 Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 03/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberL20312
Device Catalogue NumberL20312
Device Lot Number5325317
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 Received04/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2018
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: 03/18/2020 Patient Sequence Number: 1
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