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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MODULAR CATHCART BALL 50MM OD HEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI

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DEPUY ORTHOPAEDICS INC US MODULAR CATHCART BALL 50MM OD HEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI Back to Search Results
Model Number 1363-50-000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); No Code Available (3191)
Event Date 11/25/2019
Event Type  Injury  
Manufacturer Narrative
(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 painful hip. Converted monopolar hemi hip to a total hip. He removed the head and spacer. Numbers were not obtainable from the spacer. No further information is available. Doi: (b)(6) 2011; dor: (b)(6) 2019; right hip.
 
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Brand NameMODULAR CATHCART BALL 50MM OD
Type of DeviceHEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6103142063
MDR Report Key9476005
MDR Text Key184896109
Report Number1818910-2019-123230
Device Sequence Number1
Product Code LZY
UDI-Device Identifier10603295032823
UDI-Public10603295032823
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 company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1363-50-000
Device Catalogue Number136350000
Device Lot NumberE5PE31
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 Received01/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/04/2010
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: 12/16/2019 Patient Sequence Number: 1
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