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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
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/28/2018
Event Type  Malfunction  
Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

Dr (b)(6), (b)(6) hospital (b)(6) 2018. Using the kho neck segment when trialing the stem and head, when surgeon went to change the trial head option the metal o-ring came off. Neck segment could be used but head would not stay on tight and secure. Female patient id: (b)(6).

 
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.

 
Manufacturer Narrative

Product complaint #: (b)(4). Investigation summary: examination of the device confirmed the failure mode as reported. 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. 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 NameCORAIL AMT NECK SEG 135D KHO
Type of DeviceHIP INSTRUMENTS : FEMORAL TRIALS
Manufacturer (Section D)
DEPUY FRANCE SAS - 3003895575
7 allee irene joliot-curie
b.p. 256
saint priest cedex 69801
FR 69801
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
bp 256
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-XXXX
6103142063
MDR Report Key7453735
MDR Text Key106260217
Report Number1818910-2018-58109
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK142004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 03/28/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/24/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberL94006
Device LOT NumberNB103973
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/24/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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