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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL AMT SZ14 135 HIGH COL CORAIL LINE EXTENSION IMPLANTS : HIP FEMORAL STEM

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DEPUY FRANCE SAS - 3003895575 CORAIL AMT SZ14 135 HIGH COL CORAIL LINE EXTENSION IMPLANTS : HIP FEMORAL STEM Back to Search Results
Model Number L971114
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Muscle Spasm(s) (1966); No Code Available (3191)
Event Date 12/12/2019
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 spasm with movement. Event is not serious and is considered moderate. Event is not related to device and is probably related to procedure. Date of implantation: (b)(6) 2019, date of event (onset): (b)(6) 2019, (left hip). Treatment: unspecified medical intervention and unspecified surgical intervention, (not revision).
 
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Brand NameCORAIL AMT SZ14 135 HIGH COL
Type of DeviceCORAIL LINE EXTENSION IMPLANTS : HIP 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 IRELAND 9616671
loughbeg, ringaskiddy co.
cork LS11 8DT
EI LS11 8DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key9757228
MDR Text Key182294349
Report Number1818910-2020-06057
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberL971114
Device Catalogue NumberL971114
Device Lot Number9263680
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 Received04/24/2020
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: 02/26/2020 Patient Sequence Number: 1
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