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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN DEPUY STEM   HIP FEMORAL STEM/SLEEVE

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DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN DEPUY STEM   HIP FEMORAL STEM/SLEEVE Back to Search Results
Catalog Number UNK-HIP
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Death (1802); Pain (1994)
Event Type  Injury  
Manufacturer Narrative
Additional narrative: no device associated with this report was received for examination. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will 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.
 
Manufacturer Narrative
This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time. A follow-up medwatch will be filed as appropriate. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Aug 30, 2017: litigation received. Litigation alleges high chromium-cobalt levels, physical and mental pain. And death. No part and lot information provided.
 
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Brand NameUNKNOWN DEPUY STEM  
Type of DeviceHIP FEMORAL STEM/SLEEVE
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46581
5743725905
MDR Report Key6903451
MDR Text Key104473415
Report Number1818910-2017-25653
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Type of Report Initial,Followup
Report Date 08/30/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK-HIP
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/24/2017
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

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