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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK ATTUNE KNEE PATELLA
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DEPUY IRELAND - 9616671 UNK ATTUNE KNEE PATELLA Back to Search Results
Catalog Number UNK ATTUNE KNEE PATELLA
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 04/13/2021
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 confirmed infection and loosening of the unknown component at the implant to bone interface.Unknown cement was used.Cement spacer implanted.Doi: (b)(6) 2019 (tibial insert).Unknown (other implants explanted).Dor: (b)(6) 2021.Left knee.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
 
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Brand Name
UNK ATTUNE KNEE PATELLA
Type of Device
PATELLA
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key11726278
MDR Text Key247336718
Report Number1818910-2021-08744
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,health
Type of Report Initial,Followup
Report Date 04/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK ATTUNE KNEE PATELLA
Was Device Available for Evaluation? No
Date Manufacturer Received05/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ATTUNE CEMENTED STEM; ATTUNE PRESS FIT STEM; ATTUNE REVISION FEMUR SZ 8 LEFT; ATTUNE REVISION INSERT SZ 8 16MM; ATTUNE RP REVISION TRAY SZ 7; ATTUNE TIBIAL SLEEVE; ATTUNE CEMENTED STEM; ATTUNE PRESS FIT STEM; ATTUNE REVISION FEMUR SZ 8 LEFT; ATTUNE REVISION INSERT SZ 8 16MM; ATTUNE RP REVISION TRAY SZ 7; ATTUNE TIBIAL SLEEVE
Patient Outcome(s) Required Intervention;
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