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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 CORAIL AMT COLLAR SIZE 10 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

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DEPUY FRANCE SAS 3003895575 CORAIL AMT COLLAR SIZE 10 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM Back to Search Results
Catalog Number 3L92500
Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)
Patient Problems Pain (1994); Tissue Damage (2104); Inadequate Osseointegration (2646); No Code Available (3191)
Event Date 08/04/2015
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. Initial reporter occupation: non-healthcare professional ¿ attorney. (b)(4).
 
Event Description
Litigation alleges patient was revised to address pain and slipping and loosening sensations. Ppf alleges loosening of stem and metal wear/metallosis. Doi: (b)(6) 2008 - dor: (b)(6) 2015 (left hip).
 
Manufacturer Narrative
Product complaint # (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, a follow-up medwatch will be filed as appropriate.
 
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Brand NameCORAIL AMT COLLAR SIZE 10
Type of DeviceCORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY FRANCE SAS 3003895575
7 allée irène joliot curie
bp 256
saint priest cedex 69801
FR 69801
Manufacturer (Section G)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
b.p. 256
cork 69801
EI 69801
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
b.p. 256
west chester, PA 19380
6103142063
MDR Report Key8202314
MDR Text Key131587189
Report Number1818910-2018-79320
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 11/30/2018
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 Date03/31/2012
Device Catalogue Number3L92500
Device Lot Number2360411
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 Received04/30/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/25/2007
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: 12/28/2018 Patient Sequence Number: 1
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