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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK KNEE TIBIAL INSERT ATTUNE REVISION
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DEPUY IRELAND - 9616671 UNK KNEE TIBIAL INSERT ATTUNE REVISION Back to Search Results
Catalog Number UNK KNEE TIBIAL INSERT ATTUNE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 02/01/2021
Event Type  Injury  
Manufacturer Narrative
(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
This complaint is to capture the revision surgery reported in (b)(4).It was reported that the surgeon carried out an attune revision removal (femoral/tibial components with fully porus sleeves and 60mm pressfit stems).The patient had an infection.Doi: unknown, dor: (b)(6) 2021, unknown knee.
 
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Brand Name
UNK KNEE TIBIAL INSERT ATTUNE REVISION
Type of Device
KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key11357713
MDR Text Key232857693
Report Number1818910-2021-03496
Device Sequence Number1
Product Code NJL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK KNEE TIBIAL INSERT ATTUNE
Was Device Available for Evaluation? No
Date Manufacturer Received02/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNK KNEE FEMORAL ATTUNE REVISION; UNK KNEE FEMORAL SLEEVE ATTUNE REVISION; UNK KNEE STEM ATTUNE REVISION; UNK KNEE STEM ATTUNE REVISION; UNK KNEE TIBIAL SLEEVE ATTUNE REVISION; UNK KNEE TIBIAL TRAY ATTUNE REVISION; UNK KNEE FEMORAL ATTUNE REVISION; UNK KNEE FEMORAL SLEEVE ATTUNE REVISION; UNK KNEE STEM ATTUNE REVISION; UNK KNEE STEM ATTUNE REVISION; UNK KNEE TIBIAL SLEEVE ATTUNE REVISION; UNK KNEE TIBIAL TRAY ATTUNE REVISION
Patient Outcome(s) Required Intervention;
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