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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL AMT NECK SEG 135D KHO; HIP INSTRUMENTS : FEMORAL TRIALS
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DEPUY FRANCE SAS - 3003895575 CORAIL AMT NECK SEG 135D KHO; HIP INSTRUMENTS : FEMORAL TRIALS Back to Search Results
Catalog Number L94006
Medical Device Problem Code Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/23/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the complaint is justified, examination of the photos confirmed the failure mode no further actions identified.The complaint shall be closed with a justified conclusion; entered into the complaints database and monitored through trend analysis.Post market surveillance is per (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event or Problem Description
Blood and debris gets caught behind neck trial o rings.No delay to procedure.
 
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Brand Name
CORAIL AMT NECK SEG 135D KHO
Common Device Name
HIP INSTRUMENTS : FEMORAL TRIALS
Manufacturer (Section D)
DEPUY FRANCE SAS - 3003895575
7 allee irene joliot-curie
b.p. 256
saint priest cedex 69801
FR  69801
MDR Report Key8190198
Report Number1818910-2018-79019
Device Sequence Number1900299
Product Code LXH
UDI-Device Identifier10603295325178
UDI-Public10603295325178
Combination Product (Y/N)N
Initial Reporter CountryAS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue NumberL94006
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/29/2018
Initial Report FDA Received Date12/21/2018
Patient Sequence Number1
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