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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 15 HIP FEMORAL STEM

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DEPUY FRANCE SAS - 3003895575 CORAIL2 NON COL HO SIZE 15 HIP FEMORAL STEM Back to Search Results
Catalog Number L20315
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Test Result (2695)
Event Date 06/25/2013
Event Type  Injury  
Manufacturer Narrative
(b)(4). Investigation summary: no device associated with this report was received for examination. A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution. Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. Corrective action was not indicated. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Initial reporter occupation: non-healthcare professional ¿ attorney.
 
Event Description
Litigation alleges pain and decreased range of motion. Ppf alleges abductor muscle repair and elevated metal ions. Doi: (b)(6) 2010 - dor: none reported (right hip).
 
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Brand NameCORAIL2 NON COL HO SIZE 15
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
1210 ward avenue
b.p. 256
west chester, PA 19380
6107428552
MDR Report Key8202344
MDR Text Key131589057
Report Number1818910-2018-79327
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
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
Report Date 12/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2015
Device Catalogue NumberL20315
Device Lot Number5030639
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/03/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/06/2010
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: 12/28/2018 Patient Sequence Number: 1
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