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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL REVISION STEM HO 15; CORAIL KAR REVISION IMPLANT : HIP FEMORAL STEM
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DEPUY FRANCE SAS - 3003895575 CORAIL REVISION STEM HO 15; CORAIL KAR REVISION IMPLANT : HIP FEMORAL STEM Back to Search Results
Model Number L98015
Device Problem Fracture (1260)
Patient Problems Bone Fracture(s) (1870); Not Applicable (3189); No Code Available (3191)
Event Date 05/29/2020
Event Type  Injury  
Manufacturer Narrative
Product complaint # (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
Deformed corail revision stem and trial after implanting.One of the distal parts is going outside the bone because of a via falsa.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.¿ removed h6 (patient) 3191 (device revision or replacement).No code available is used to capture surgery prolonged.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Manufacturer Narrative
Product complaint (b)(4).Investigation summary: examination of the returned device and provided x-ray image confirms the reported observation.The root cause is attributed to inadvertent user error.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 5358173.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Device history review lot 5358173.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.H10 additional narrative: added: e1 (facility name).Corrected: g1 (physical manufacturer).
 
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Brand Name
CORAIL REVISION STEM HO 15
Type of Device
CORAIL KAR REVISION 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
MDR Report Key10148485
MDR Text Key194954929
Report Number1818910-2020-13710
Device Sequence Number1
Product Code LWJ
UDI-Device Identifier10603295262343
UDI-Public10603295262343
Combination Product (y/n)N
PMA/PMN Number
K093736
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 05/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberL98015
Device Catalogue NumberL98115
Device Lot Number5358173
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/25/2020
Initial Date Manufacturer Received 05/29/2020
Initial Date FDA Received06/12/2020
Supplement Dates Manufacturer Received06/25/2020
06/25/2020
07/28/2020
Supplement Dates FDA Received06/26/2020
06/29/2020
07/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CORAIL REVISION STEM STD 15; TRIAL CORAIL REVISION STEM 15; CORAIL REVISION STEM STD 15; TRIAL CORAIL REVISION STEM 15
Patient Outcome(s) Required Intervention;
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