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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 1818910 TAPERED SPACER ARTICUL/EZE +0 HEMI HIP IMPLANT : HIP FEMORAL AUGMENT

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DEPUY ORTHOPAEDICS INC US 1818910 TAPERED SPACER ARTICUL/EZE +0 HEMI HIP IMPLANT : HIP FEMORAL AUGMENT Back to Search Results
Catalog Number 136310000
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 09/19/2018
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 infection.
 
Manufacturer Narrative
Product complaint # (b)(4). Investigation summary: 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.
 
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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 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS INC US 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46582-0988
5743725905
MDR Report Key7947051
MDR Text Key123074026
Report Number1818910-2018-71766
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number136310000
Device Lot NumberHX4522
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 Received11/08/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/21/2018
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: 10/09/2018 Patient Sequence Number: 1
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