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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TAPERED SPACER ARTICUL/EZE +0 HEMI HIP IMPLANT : HIP FEMORAL AUGMENT

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DEPUY ORTHOPAEDICS INC US TAPERED SPACER ARTICUL/EZE +0 HEMI HIP IMPLANT : HIP FEMORAL AUGMENT Back to Search Results
Model Number 1363-10-000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); No Code Available (3191)
Event Date 10/23/2020
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
The patient was revised due to infection and loosening of the femoral stem at the cement to implant interface. Competitor bone cement was used. It was converted from a hemi to a total hip replacement. No surgical delay noted. Doi: (b)(6) 2020, dor: (b)(6) 2020, left hip.
 
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Brand NameTAPERED SPACER ARTICUL/EZE +0
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
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key10803632
MDR Text Key215121938
Report Number1818910-2020-24144
Device Sequence Number1
Product Code LZY
UDI-Device Identifier10603295032670
UDI-Public10603295032670
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 10/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1363-10-000
Device Catalogue Number136310000
Device Lot NumberJ5123J
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 Received12/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/25/2020
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: 11/06/2020 Patient Sequence Number: 1
Treatment
CEMENTRALIZER 13.0; MODULAR CATHCART BALL 56MM OD; SUMMIT BASIC CEMENTED SZ 7; TAPERED SPACER ARTICUL/EZE +0
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