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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL ANAT PAT 32MM ATTUNE IMPLANT : KNEE PATELLA

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DEPUY IRELAND - 9616671 ATTUNE MEDIAL ANAT PAT 32MM ATTUNE IMPLANT : KNEE PATELLA Back to Search Results
Model Number 1518-10-032
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 03/30/2021
Event Type  Injury  
Manufacturer Narrative
Product complaint # (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 address painful right knee. No additional information is available. No loosening and no delay in surgery. Doi: (b)(6) 2018. Dor: (b)(6) 2021; right knee.
 
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Brand NameATTUNE MEDIAL ANAT PAT 32MM
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 Key11671804
MDR Text Key245585983
Report Number1818910-2021-08011
Device Sequence Number1
Product Code OIY
UDI-Device Identifier10603295056621
UDI-Public10603295056621
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P830055
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 03/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1518-10-032
Device Catalogue Number151810032
Device Lot Number8646635
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 Received05/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/17/2017
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: 04/15/2021 Patient Sequence Number: 1
Treatment
ATTUNE PS RP INSRT SZ5 6MM; UNKNOWN BONE CEMENT
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