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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 CORAIL2 STD SIZE 11; HIP FEMORAL STEM/SLEEVE
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DEPUY FRANCE SAS 3003895575 CORAIL2 STD SIZE 11; HIP FEMORAL STEM/SLEEVE Back to Search Results
Catalog Number 3L92511
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Fall (1848); Foreign Body Reaction (1868); Pain (1994); Tissue Damage (2104); Discomfort (2330); Injury (2348); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); Not Applicable (3189); No Code Available (3191)
Event Date 03/02/2015
Event Type  Injury  
Event Description
Litigation alleges the patient suffers from pain, discomfort, and toxic cobalt-chromium metal ions and particles to be released into the blood, tissue, and bone.
 
Manufacturer Narrative
This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: unavailable.This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.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.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
Manufacturer Narrative
Product complaint #
=
> (b)(4).Investigation summary
=
> no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot
=
> null.Device history batch
=
> null.Device history review
=
> null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Litigation alleges the patient suffers from pain, discomfort, and toxic cobalt-chromium metal ions and particles to be released into the blood, tissue, and bone.Update ad 20 apr 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and sticker sheets.In addition to what was previously alleged, ppf alleges metallosis and metal wear.Updated lot and product number of head, liner, and stem.Added cup since it was revised on the first revision.Updated patient identifier and date of revision.Doi: (b)(6) 2010 ¿ dor: (b)(6) 2015 (right hip).
 
Event Description
Litigation alleges the patient suffers from pain, discomfort, and toxic cobalt-chromium metal ions and particles to be released into the blood, tissue, and bone.Update ad (b)(6) 2018: com-(b)(4).Has been re-opened under (b)(4) due to the receipt of ppf and sticker sheets.In addition to what was previously alleged, ppf alleges metallosis and metal wear.Updated lot and product number of head, liner, and stem.Added cup since it was revised on the first revision.Updated patient identifier and date of revision.Doi: (b)(6) 2010 ¿ dor: (b)(6) 2015 (right hip).
 
Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Udi: (b)(4).
 
Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.   additional narrative: added (age), weight, description of event or problem, other relevant history and adverse event problem (patient and device code).
 
Event Description
Pfs reported cracking and crunching noise and hip would give way and patient would randomly fall while walking.After review of medical records, the patient was revised for right failed tha, symptomatic metal on metal.Operative notes reported that the abductor were poor in quality and had some evidence of metallosis.There was evident of some trunnionosis.There was a small amount of bone loss around the posterior peg.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H6 patient code: no code available (3191) was used to capture surgical intervention.Product complaint # (b)(4).No device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
CORAIL2 STD SIZE 11
Type of Device
HIP FEMORAL STEM/SLEEVE
Manufacturer (Section D)
DEPUY FRANCE SAS 3003895575
7 allée irène joliot curie
b.p. 256
saint priest cedex IN 69801
FR  69801
MDR Report Key4443172
MDR Text Key5383487
Report Number1818910-2015-11779
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number3L92511
Device Lot Number2808452
Was Device Available for Evaluation? No
Date Manufacturer Received06/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age63 YR
Patient Weight84
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