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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 LAT COXA VARA SIZE 12 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

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DEPUY FRANCE SAS - 3003895575 CORAIL2 LAT COXA VARA SIZE 12 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM Back to Search Results
Model Number 3L93712
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/05/2020
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
It was reported that the patient received a revision due to metallosis and metal poisoning. The hip bone and surrounding muscle had severe degeneration due to the elevated ions. The sup, head and liner were revised. The stem was retained. Doi: (b)(6) 2009, dor: (b)(6) 2020 (head), dor: (b)(6) 2020 (cup, head, stem), left hip.
 
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Brand NameCORAIL2 LAT COXA VARA SIZE 12
Type of DeviceCORAIL AMT CEMENTLESS IMPLANT : 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 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 Key11612921
MDR Text Key243734281
Report Number1818910-2021-06903
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
K070554
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number3L93712
Device Catalogue Number3L93712
Device Lot Number2706867
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/15/2008
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: 04/05/2021 Patient Sequence Number: 1
Treatment
12/14 ARTICUL 40MM M SPEC+12; CORAIL2 LAT COXA VARA SIZE 12; PINNACLE 100 HA ACET CUP 56MM; PINNACLE MTL INS NEUT40IDX56OD; PINNACLE MTL INS NEUT40IDX56OD
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