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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 35MM ATTUNE IMPLANT : KNEE PATELLA

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DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 35MM ATTUNE IMPLANT : KNEE PATELLA Back to Search Results
Model Number 1518-20-035
Device Problem Naturally Worn (2988)
Patient Problems Cyst(s) (1800); Granuloma (1876); Pain (1994); Synovitis (2094); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/26/2016
Event Type  Injury  
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Brand NameATTUNE MEDIAL DOME PAT 35MM
Type of DeviceATTUNE IMPLANT : KNEE PATELLA
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI
Manufacturer (Section G)
CORK MFG & MATERIAL WAREHOUSE
loughbeg ringaskiddy
cork
EI
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581
6107428552
MDR Report Key11658803
Report Number1818910-2021-07826
Device Sequence Number1
Product Code OIY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP830055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/29/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/13/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2018
Device MODEL Number1518-20-035
Device Catalogue Number151820035
Device LOT Number7813686
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/20/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/10/2014
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: 04/13/2021 Patient Sequence Number: 1
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