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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 STD SIZE 12; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
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DEPUY FRANCE SAS - 3003895575 CORAIL2 STD SIZE 12; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM Back to Search Results
Model Number 3L92512
Device Problem Fracture (1260)
Patient Problems Adhesion(s) (1695); Hematoma (1884); Pain (1994); Ambulation Difficulties (2544); Insufficient Information (4580)
Event Date 12/18/2020
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
A hip stem broke suddenly.Doi: (b)(6) 2017.Patient was also revised on the (b)(6) 2018 with a femoral head and neck replacement due to rezidivized luxation.No further information available.
 
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: 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: device manufacturing records have been reviewed.No related deviations or anomalies identified.10 pieces were manufactured march 08 2017 per specification.Raw material certifications also met specification.Device history review: device manufacturing records have been reviewed.No related deviations or anomalies identified.10 pieces were manufactured march 08 2017 per specification.Raw material certifications also met specification.
 
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.
 
Event Description
Explant will be available for investigation.No surgical delay.Affected side: right.Was the patient experiencing adverse symptoms that led to the revision surgery: hip-tep fracture and need to revise stem - up to now no complication.
 
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).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.H10 additional narrative: added: b1 (is adverse event), b2 (is required intervention) and b5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d6b and h6 (clinical codes).
 
Event Description
On (b)(6) 2017, the patient underwent a right primary hip arthroplasty due to head necrosis.Depuy product were implanted.There were no indicated intra-operative complications.On (b)(6) 2018, the patient underwent a right hip revision due to four previous dislocations.The depuy head is removed and replaced with a competitor head and adapter onto the corail stem.The femoral stem, acetabular liner, acetabular cup, and hole eliminator were retained.The surgeon noted removal of scar tissue.There were no indicated intra-operative complications.Task initiated to create a new pc to capture the event.On (b)(6) 2020, the patient underwent a second right hip revision due to pain, walking difficulty, and stem implant fracture.The surgeon noted removing scar tissue and small amounts of older hematomas.The corail stem and competitor head and adapter were revised.There were no indicated intra-operative complications.
 
Manufacturer Narrative
Product complaint (b)(4).Investigation summary: investigative update: 21 / may / 2021.The femoral stem has been provided for evaluation.Visual examination of the returned device confirms the reported material fracture.Evaluation by a depuy material scientist found no material or manufacturing defects that could have contributed to fracture.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: device manufacturing records have been reviewed.No related deviations or anomalies identified.(b)(4) pieces were manufactured march 08 2017 per specification.Raw material certifications also met specification.Device history review: device manufacturing records have been reviewed.No related deviations or anomalies identified.(b)(4) pieces were manufactured march 08 2017 per specification.Raw material certifications also met specification.
 
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Brand Name
CORAIL2 STD SIZE 12
Type of Device
CORAIL 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
MDR Report Key11133709
MDR Text Key225732450
Report Number1818910-2021-00633
Device Sequence Number1
Product Code KWA
UDI-Device Identifier10603295168782
UDI-Public10603295168782
Combination Product (y/n)N
PMA/PMN Number
K190344
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number3L92512
Device Catalogue Number3L92512
Device Lot Number8480282
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2021
Date Manufacturer Received06/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
APEX HOLE ELIM POSITIVE STOP; CORAIL2 STD SIZE 12; DELTA CER HEAD 12/14 36MM +1.5; PINN MAR +4 NEUT 36IDX60OD; PINNACLE 100 ACET CUP 60MM
Patient Outcome(s) Required Intervention;
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