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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 35MM ATTUNE IMPLANT : KNEE PATELLA

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DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 35MM ATTUNE IMPLANT : KNEE PATELLA Back to Search Results
Model Number 1518-20-035
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Joint Laxity (4526)
Event Date 11/17/2021
Event Type  Injury  
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.
 
Event Description
Patient was revised due to complaints of patella being unstable and knee being loose about the joint. Patient had patella revision with poly swap on (b)(6) 2021. Patient has a history of left total knee last (b)(6) 2016. Doi: (b)(6) 2016 ; dor: (b)(6) 2021 left knee.
 
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Brand NameATTUNE MEDIAL DOME PAT 35MM
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
1210 ward av
west chester, PA 19380
6107428552
MDR Report Key12909888
MDR Text Key281526739
Report Number1818910-2021-26777
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 Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1518-20-035
Device Catalogue Number151820035
Device Lot Number8319046
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/29/2016
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: 12/01/2021 Patient Sequence Number: 1
Treatment
ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS RP INSRT SZ 5 7MM
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