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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 38MM ATTUNE IMPLANT : KNEE PATELLA

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DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 38MM ATTUNE IMPLANT : KNEE PATELLA Back to Search Results
Model Number 1518-20-038
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Loss of Range of Motion (2032)
Event Date 11/29/2021
Event Type  Injury  
Event Description
Patient was revised due to surgeon thought that the patella was too thick causing some pain and low limited rom. The patella implant, tibial insert and femoral component were explanted. More patella bone was resected, the femur was downsized to a size 3 with a crs femoral component. The tibial base plates was left in situ. Patient had done her knee by a surgeon on (b)(6) 2020 at (b)(6). Doi: (b)(6) 2020 (femoral & patella), (b)(6) 2021 (tibial insert), dor: (b)(6) 2021, right knee.
 
Manufacturer Narrative
Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand NameATTUNE MEDIAL DOME PAT 38MM
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, munster
EI
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 19380
6107428552
MDR Report Key12967603
MDR Text Key281979321
Report Number1818910-2021-27584
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,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1518-20-038
Device Catalogue Number151820038
Device Lot Number9402089
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/18/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/09/2021 Patient Sequence Number: 1
Treatment
ATTUNE CR FEM RT SZ 4 CEM; ATTUNE MEDIAL DOME PAT 38MM; UNK ATTUNE KNEE TIBIAL INSERT; UNK ATTUNE KNEE TIBIAL TRAY
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