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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 6 8MM ATTUNE IMPLANT : KNEE TIBIAL INSERT

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DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 6 8MM ATTUNE IMPLANT : KNEE TIBIAL INSERT Back to Search Results
Model Number 1516-40-608
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Osteolysis (2377); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 12/20/2018
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

Initial report: patient was revised to address loosening of the tibial component at cement to implant interface. Cement manufacturer was unknown. There was no cement bond to implant. Doi: (b)(6) 2014 dor: (b)(6) 2018 left knee. Further information received 02 february 2021 and reviewed: patient received a left primary attune tka to treat pain secondary to tricompartmental osteoarthritis. The patella was resurfaced and depuy smartset gentamycin cement x2 was utilized. The procedure was completed without complications. The surgeon notes that the patient has morbid obesity. Patient received a left knee revision to treat pain, impaired mobility, and osteolysis secondary to aseptic loosening. Upon entering the joint, the surgeon identified and excised periarticular synovitis. The surgeon notes there was femoral condyle and tibial metaphyseal osteolysis. The femoral component was loosened at an unknown interface and revised. The tibial tray was grossly loose and debonded at the cement to implant interface. The surgeon notes there was some femoral condyle and tibial metaphyseal bone loss. There was no reported product problem with the revised tibial insert. The patella was well-fixed and retained. The patient was revised with a depuy sigma revision construct utilizing depuy cement x 3. The procedure was completed without complications. Doi: (b)(6) 2014, dor: (b)(6) 2018, left knee.

 
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Brand NameATTUNE PS FB INSRT SZ 6 8MM
Type of DeviceATTUNE IMPLANT : KNEE TIBIAL INSERT
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 Key11334734
MDR Text Key232091316
Report Number1818910-2021-03123
Device Sequence Number1
Product Code OIY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK111433
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/02/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/16/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/01/2018
Device MODEL Number1516-40-608
Device Catalogue Number151640608
Device LOT Number350552
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 Received04/03/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/05/2013
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: 02/16/2021 Patient Sequence Number: 1
Treatment
ATTUNE FB TIB BASE SZ 5 CEM; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE PS FEM LT SZ 6 CEM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
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