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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL AMT COLLAR SIZE 12 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

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DEPUY FRANCE SAS - 3003895575 CORAIL AMT COLLAR SIZE 12 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM Back to Search Results
Model Number 3L92502
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Pyrosis/Heartburn (1883); Pain (1994); Rash (2033); Discomfort (2330); Depression (2361); No Code Available (3191)
Event Date 12/26/2008
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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
Medical records received. After review of medical records, it was indicated that the patient had pain and discomfort, the patient was then revised for painful right tha secondary to acetabular malposition. Operative notes reported that there was a significant synovial fluid which was benign in nature. There was a grayish discoloration to some of the tissue, indicating possible metallosis. Visit notes on (b)(6) 2008 reported that patient had weight gain due to inactivity cause by pain, heartburn, hernia, arthritic back-low back, skin rash on lower leg, numbness of right hip of upper leg and thigh and depression. Doi: (b)(6) 2007; dor: (b)(6) 2008; right hip.
 
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Brand NameCORAIL AMT COLLAR 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 Key10148968
MDR Text Key194974280
Report Number1818910-2020-13721
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 other
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number3L92502
Device Catalogue Number3L92502
Device Lot Number2437424
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 Received07/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/12/2007
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: 06/12/2020 Patient Sequence Number: 1
Treatment
ADAPTER SLEEVES 12/14 +8; ASR ACETABULAR CUPS 56; ASR UNI FEMORAL IMPL SIZE 49; CORAIL AMT COLLAR SIZE 12
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