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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 Wound Dehiscence (1154); Adhesion(s) (1695); Chest Pain (1776); Edema (1820); Erythema (1840); Fatigue (1849); Fever (1858); Headache (1880); Unspecified Infection (1930); Pain (1994); No Code Available (3191)
Event Date 07/12/2018
Event Type  Injury  
Manufacturer Narrative
Product complaint #: (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
Ppf alleged infection. Pfs alleged pain, redness, and drainage. After review of medical records, patient was revised to address left infected total hip arthroplasty. Upon physical examination on (b)(6) 2018, patient has fever. Pain, swelling, redness, drainage, throbbing frontal headache, squeezing chest pain, and fatigue were alleged. Patient said incision is draining yellow to brown fluid but drainage has no odor. Operative notes indicated a communication was found between the superficial space and deep to the fascia. The superficial space was debrided. An excisional debridement of skin, subcutaneous tissue, fat and the fascia were done. The superficial space was then copiously irrigated. There was fluid deep to the fascia with purulence about 80 cc of purulent fluid. The capsule was debulked and scar tissue was removed. Scar tissue was also removed around the acetabular component. A thourough debridement of an infected looking tissue was done around the acetabulum and femur. After all infected looking tissues were excised the hip was irrigated with 9 liters of irrigation as well as betadine irrigation. Based on flouroscopy, there was no iatrogenic fractures. Laboratory results indicated infection. Doi: (b)(6) 2018 (liner & head) - dor: (b)(6) 2018 (left hip). Doi: (b)(6) 2010 (cup & stem).
 
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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 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 Key9836925
MDR Text Key191243405
Report Number1818910-2020-08109
Device Sequence Number1
Product Code KWA
UDI-Device Identifier10603295258056
UDI-Public10603295258056
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 02/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2014
Device Model NumberL20314
Device Catalogue NumberL20314
Device Lot Number5018012
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 Received04/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/07/2009
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: 03/16/2020 Patient Sequence Number: 1
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