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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM RT SZ 5 CEM ATTUNE IMPLANT : KNEE FEMORAL

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DEPUY IRELAND - 9616671 ATTUNE PS FEM RT SZ 5 CEM ATTUNE IMPLANT : KNEE FEMORAL Back to Search Results
Model Number 1504-10-205
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Inflammation (1932)
Event Date 03/06/2018
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
Initial report: the patient was revised to address collapse medial tibial plateau and loosening of the tibia at the cement to implant interface, competitor cement was used. Tibial baseplate prosthesis was grossly loose and removed from patient's bone by hand; metalosis in the joint's soft-tissue was discovered. Bottom side of the baseplate appeared to be covered in fat with lipid wave infiltration. Doi: (b)(6) 2013; dor: (b)(6) 2018; right knee. Medical records were then received and reviewed and provided the following: on (b)(6) 2018, the patient underwent a right knee revision to address metallosis, tibial tray migration, and tibial loosening at the cement to implant interface. The surgeon noted minimal bone loss with removal of the tibial tray and well-fixed femoral component. A near complete synovectomy was completed due to inflamed tissue. The tibial tray, tibial insert, and femoral component were revised. The patellar component was retained. The patient was revised with depuy products and depuy cement x 3. There were no indicated intra-operative complications.
 
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Brand NameATTUNE PS FEM RT SZ 5 CEM
Type of DeviceATTUNE IMPLANT : KNEE FEMORAL
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI
Manufacturer (Section G)
JTE RAYNHAM MFG SITE
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581
6107428552
MDR Report Key12024803
MDR Text Key263143505
Report Number1818910-2021-12987
Device Sequence Number1
Product Code OIY
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 other
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1504-10-205
Device Catalogue Number150410205
Device Lot Number319479
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 Received10/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/18/2012
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: 06/18/2021 Patient Sequence Number: 1
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