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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM LT SZ 5 NAR CEM ATTUNE IMPLANT : KNEE FEMORAL

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DEPUY IRELAND - 9616671 ATTUNE CR FEM LT SZ 5 NAR CEM ATTUNE IMPLANT : KNEE FEMORAL Back to Search Results
Model Number 1504-00-125
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Pain (1994)
Event Date 05/14/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint #: (b)(4). Initial reporter occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Patient received primary bilateral attune tkas to treat osteoarthritis. The patella was resurfaced and an unknown number of depuy cements were used on each knee. The procedure was completed without complications. Patient received a left knee revision to treat pain secondary to loosening of the tibial tray. Upon entering the joint, scar tissue was debrided. The femoral component was well-fixed but revised. The tibial tray was loosened and debonded at the cement to implant interface and revised. There was no reported product problem with the revised tibial insert. The patella was well-fixed and retained. The patient was revised with a competitor revision knee. The procedure was completed without complications. Doi: (b)(6) 2015, dor: (b)(6) 2019, left knee.
 
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Brand NameATTUNE CR FEM LT SZ 5 NAR CEM
Type of DeviceATTUNE IMPLANT : KNEE FEMORAL
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 Key11665391
MDR Text Key245494820
Report Number1818910-2021-07920
Device Sequence Number1
Product Code OIY
UDI-Device Identifier10603295041146
UDI-Public10603295041146
Combination Product (y/n)N
Reporter Country CodeUS
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 Received04/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1504-00-125
Device Catalogue Number150400125
Device Lot Number7773990
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 Received05/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/27/2013
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: 04/14/2021 Patient Sequence Number: 1
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