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U.S. Department of Health and Human Services

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

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DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 5 NAR CEM ATTUNE IMPLANT : KNEE FEMORAL Back to Search Results
Model Number 1504-10-125
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cyst(s) (1800); Granuloma (1876); Pain (1994); Synovitis (2094); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/26/2016
Event Type  Injury  
Manufacturer Narrative

Product complaint #: (b)(4). Initial reporter occupation: lawyer. (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

On (b)(6) 2014, the patient had a left total knee arthroplasty to address degenerative arthritis, varus deformity and flexion contracture of the left knee. Depuy components, including depuy patella, and unknown cement were used during this procedure. On (b)(6) 2016, the patient had a revision left total knee, complete and totally synovectomy, excision of reactive bone cyst to address loosening of the tibial component, polyethylene and polymethylmethacrylate wear debris disease, reactive synovitis of left knee secondary to polyethylene wear debris and cement wear debris disease, cystic formation, and knee pain. During the procedure the surgeon observed necrotic looking granulation tissue, and some bone erosions. The tibial screw was noted to be grossly loose, the tibial tray had completely debonded from the cement and the cement was noted to have degraded. There was a large reactive cyst in the medial femoral condyle that was debrided. The tibial tray, tibial insert, and femoral component were revised. The surgeon also reported that the patient¿s components had subsided, but did not specify which components. Depuy components were implanted during this procedure, including depuy cement. Doi: (b)(6) 2014 dor: (b)(6) 2016 (left knee).

 
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Brand NameATTUNE PS 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 Key11658925
MDR Text Key246660713
Report Number1818910-2021-07828
Device Sequence Number1
Product Code OIY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP830055
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 Received04/13/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1504-10-125
Device Catalogue Number150410125
Device LOT Number7796563
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 Received05/20/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/01/2013
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: 04/13/2021 Patient Sequence Number: 1
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