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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 Problems Inflammation (1932); Pain (1994)
Event Date 03/11/2020
Event Type  Injury  
Manufacturer Narrative
(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
It was reported that the patient had a cortisone injection to the left knee on (b)(6) 2020. On (b)(6) 2020 medical records note the patient presents with bilateral knee pain. Updated assessment noted left knee status post revision knee arthroplasty for loose component with a secondary history of pes anserine bursitis treated with a cortisone injection with good results. Doi: (b)(6) 2014; dor: mar 19, 2019 (tibia, femur and insert - captured in (b)(4)); doe: (b)(6) 2020; 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
EI
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key11444262
MDR Text Key238628259
Report Number1818910-2021-04683
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 02/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/12/2017
Device Model Number1518-20-035
Device Catalogue Number151820035
Device Lot Number3473438
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 Received04/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/23/2012
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: 03/09/2021 Patient Sequence Number: 1
Treatment
ATTUNE CEMENTED STEM 14X30MM; ATTUNE CEMENTED STEM 14X30MM; ATTUNE CRS FEMORAL LT SZ 5 CEM; ATTUNE CRS RP INSRT SZ 5 14MM; ATTUNE DIST FEM AUG SZ 5 4MM; ATTUNE DIST FEM AUG SZ 5 4MM; ATTUNE MEDIAL DOME PAT 35MM; ATUN FEM SLV M/L 30MM FULL POR; ATUN TIB SLV M/L 29MM FULL POR; ATUNE REV RP TIB BASE SZ 4 CEM; DEPUY/CMW 2G; DEPUY/CMW 2G; DEPUY/CMW 2G; DEPUY/CMW 2G
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