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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 MODULAR CATHCART BALL 48MM OD HIP FEMORAL HEAD

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DEPUY IRELAND - 9616671 MODULAR CATHCART BALL 48MM OD HIP FEMORAL HEAD Back to Search Results
Catalog Number 136348000
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 10/28/2017
Event Type  Injury  
Manufacturer Narrative
Product complaint #
==
> pc-(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.
 
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 to address infected hip.
 
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Brand NameMODULAR CATHCART BALL 48MM OD
Type of DeviceHIP FEMORAL HEAD
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork IN
EI
Manufacturer (Section G)
JJMSZ PLANT FOR STK. & N-STK.
no. 299, changyang street
suzhou industrial park
suzhou, jiangsu 21512 -6
CH 21512-6
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46582
5743725905
MDR Report Key7057942
MDR Text Key117447966
Report Number1818910-2017-50171
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 10/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number136348000
Device Lot NumberD16072033
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 Received07/02/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/27/2016
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: 11/24/2017 Patient Sequence Number: 1
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