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U.S. Department of Health and Human Services

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

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DEPUY IRELAND - 9616671 ATTUNE MEDIAL ANAT PAT 32MM ATTUNE IMPLANT : KNEE PATELLA Back to Search Results
Model Number 1518-10-032
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Synovitis (2094)
Event Date 01/27/2021
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
(b)(4) medical records ad 27 aug 2021 were reviewed. On (b)(6) 2016, the patient had a right total knee arthroplasty to address end-stage osteoarthritis, mainly involving patellofemoral joint. Depuy components, including depuy patella and depuy cement x2 were utilized during this procedure. On (b)(6) 2021, the patient had a revision right total arthroplasty to address aseptic loosening. The femoral, tibial tray, insert, and patella were revised. The patient was negative for infection. During the procedure the surgeon observed moderate amount of synovitis as well as scar tissue. The insert showed no significant wear but was revised. The tibial tray was loose at the implant to cement interface. The femoral component was not loose to palpitation, but fairly quickly loosened after using a saw blade and osteotomes. The preoperative bone scan results showed the patella as loose. The patella was removed for concerns of loosening, but no loosening was noted during the procedure. Competitor components were implanted, including competitor patella and competitor cement x3. Doi: (b)(6) 2016 dor: (b)(6) 2021 (right knee).
 
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Brand NameATTUNE MEDIAL ANAT PAT 32MM
Type of DeviceATTUNE IMPLANT : KNEE PATELLA
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI
Manufacturer (Section G)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key12489545
MDR Text Key271954863
Report Number1818910-2021-20443
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 consumer,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2020
Device Model Number1518-10-032
Device Catalogue Number151810032
Device Lot Number8148707
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 Received10/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/10/2015
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: 09/17/2021 Patient Sequence Number: 1
Treatment
ATTUNE CR FEM RT SZ 6 NAR CEM; ATTUNE CR RP INSRT SZ 6 5MM; ATTUNE MEDIAL ANAT PAT 32MM; ATTUNE RP TIB BASE SZ 4 CEM; SMARTSET MV 40G - EO; SMARTSET MV 40G - EO
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