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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INT'L LTD. 8010379 CORAIL2 NON COL HO SIZE 14 HIP FEMORAL STEM

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DEPUY INT'L LTD. 8010379 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 Adhesion(s) (1695); Erythema (1840); Unspecified Infection (1930); Pain (1994); Fluid Discharge (2686); Swelling/ Edema (4577)
Event Date 12/27/2021
Event Type  Injury  
Event Description
Clinical adverse event received for infection deep vs superficial event is serious and is considered mild. Event is definitely not related to device and is possibly related to procedure. Date of implantation: (b)(6) 2021, date of event (onset): (b)(6) 2021, (left hip). Treatment: surgical joint aspiration, and superficial wound (superficial infections with subcutaneous induration) scrubbed with chlorhexidine and irrigated with ancef in 2 liters of fluid.
 
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.
 
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Brand NameCORAIL2 NON COL HO SIZE 14
Type of DeviceHIP FEMORAL STEM
Manufacturer (Section D)
DEPUY INT'L LTD. 8010379
st anthonys road
leeds LS11 8 DT
UK LS11 8 DT
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 Key13392168
MDR Text Key284682601
Report Number1818910-2022-01902
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070554
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberL20314
Device Catalogue NumberL20314
Device Lot Number5325284
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/27/2022
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: 01/31/2022 Patient Sequence Number: 1
Treatment
ARTICULEZE M HEAD 36MM +5; CORAIL STEM COLLARLESS HI OFFSET SZ 14; PINNACLE ALTRX 54MM X 36MM +4 NEUTRAL; PINNACLE SHELL SECTOR 54MM
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