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U.S. Department of Health and Human Services

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

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DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 32MM ATTUNE IMPLANT : KNEE PATELLA Back to Search Results
Model Number 1518-20-032
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 03/31/2021
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
Pt originally had a knee replacement with surgeon, replacing all components including patella. After surgery the physio had asked him to do a standing jump & patient reported his knee not feeling quite right after the jump. Surgeon explored all options to help patient including mua & scoping patient. Surgeon as last option decided to replace existing patella. Surgeon decided to change from a medial dome patella to anatomic patella. 2 mixes of cmw2 used in primary.
 
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Brand NameATTUNE MEDIAL DOME 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 Key11691360
MDR Text Key246477563
Report Number1818910-2021-08263
Device Sequence Number1
Product Code OIY
UDI-Device Identifier10603295056676
UDI-Public10603295056676
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P830055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1518-20-032
Device Catalogue Number151820032
Device Lot Number8901357
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 Received06/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/03/2018
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: 04/19/2021 Patient Sequence Number: 1
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