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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL AMT NECK SEG 125D KLA; HIP INSTRUMENTS : FEMORAL TRIALS
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DEPUY FRANCE SAS - 3003895575 CORAIL AMT NECK SEG 125D KLA; HIP INSTRUMENTS : FEMORAL TRIALS Back to Search Results
Catalog Number L94004
Medical Device Problem Code Component Missing (2306)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/25/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the devices were reviewed and the failure mode was confirmed.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: nb109568.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
Short neck trial option is missing the metal ring at the base of the trunnion which secures the head trial in place.
 
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Brand Name
CORAIL AMT NECK SEG 125D KLA
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 Key8054683
Report Number1818910-2018-75045
Device Sequence Number1653681
Product Code LXH
UDI-Device Identifier10603295325154
UDI-Public10603295325154
Combination Product (Y/N)N
Initial Reporter CountryAS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,other
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/07/2018
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 NumberL94004
Device Lot NumberNB109568
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/26/2018
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/07/2018
Initial Report FDA Received Date11/09/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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