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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TAPERED SPACER ARTICUL/EZE +5 HEMI HIP IMPLANT : HIP FEMORAL AUGMENT

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DEPUY ORTHOPAEDICS INC US TAPERED SPACER ARTICUL/EZE +5 HEMI HIP IMPLANT : HIP FEMORAL AUGMENT Back to Search Results
Catalog Number 136312000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); No Code Available (3191)
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
Revision due to infection.
 
Manufacturer Narrative
Product complaint # (b)(4). Investigation summary
==
> no device associated with this report was received for examination. A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution. Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications. 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. 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 NameTAPERED SPACER ARTICUL/EZE +5
Type of DeviceHEMI HIP IMPLANT : HIP FEMORAL AUGMENT
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 Key9342975
MDR Text Key167123113
Report Number1818910-2019-116999
Device Sequence Number1
Product Code LZY
UDI-Device Identifier10603295032687
UDI-Public10603295032687
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 10/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number136312000
Device Lot NumberJ13D49
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 Received12/05/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/30/2019
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: 11/19/2019 Patient Sequence Number: 1
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