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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 Device Damaged Prior to Use (2284)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2021
Event Type  malfunction  
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
Scratch on implant. No surgical delay. No patient consequence.
 
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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 Key12095865
Report Number1818910-2021-14050
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,Followup
Report Date 06/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1518-10-032
Device Catalogue Number151810032
Device Lot Number9771804
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/25/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
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