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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC.1818910 MODULAR CATHCART BALL 50MM OD HIP FEMORAL HEAD

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DEPUY ORTHOPAEDICS, INC.1818910 MODULAR CATHCART BALL 50MM OD HIP FEMORAL HEAD Back to Search Results
Catalog Number 136350000
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 06/17/2017
Event Type  Injury  
Manufacturer Narrative
No device associated with this report was received for examination. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. 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 still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed. (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
Patient was revised to address infection.
 
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Brand NameMODULAR CATHCART BALL 50MM OD
Type of DeviceHIP FEMORAL HEAD
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 Key6713427
MDR Text Key104182623
Report Number1818910-2017-21159
Device Sequence Number1
Product Code LZY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K903084
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number136350000
Device Lot Number604102
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 Received08/11/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/08/2014
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: 07/14/2017 Patient Sequence Number: 1
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