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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 CORAIL2 NON COL HO SIZE 10 HIP FEMORAL STEM/SLEEVE

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DEPUY FRANCE SAS 3003895575 CORAIL2 NON COL HO SIZE 10 HIP FEMORAL STEM/SLEEVE Back to Search Results
Catalog Number L20310
Device Problem Loss of Osseointegration (2408)
Patient Problem Pain (1994)
Event Date 01/09/2017
Event Type  Injury  
Manufacturer Narrative
This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed. Udi: (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
The patient was revised to address pain, stem loosening and metallosis.
 
Manufacturer Narrative
The patient was revised to address pain, stem loosening and metallosis. Examination of the reported devices was not possible as they were not returned. A search of the complaints databases and/or a review of device history records were not possible as the required product/lot code combinations were not provided. The investigation can draw no conclusion regarding the reported event with the information available. Based on the inability to determine root cause, the need for corrective action has not been indicated. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
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Brand NameCORAIL2 NON COL HO SIZE 10
Type of DeviceHIP FEMORAL STEM/SLEEVE
Manufacturer (Section D)
DEPUY FRANCE SAS 3003895575
7 allée irène joliot curie
bp 256
saint priest cedex, rhone alpes 69801
FR 69801
Manufacturer (Section G)
DEPUY FRANCE SAS 3003895575
7 allée irène joliot curie
bp 256
saint priest cedex, rhone alpes 69801
FR 69801
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46581
5743725905
MDR Report Key6286796
MDR Text Key66066219
Report Number1818910-2017-11627
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042992
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberL20310
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/10/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/30/2017 Patient Sequence Number: 1
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