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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK ATTUNE KNEE PATELLA; ATTUNE PATELLA
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DEPUY IRELAND - 9616671 UNK ATTUNE KNEE PATELLA; ATTUNE 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 11/19/2020
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
The patient was revised to address infection.Doi: unknown.Dor: (b)(6) 2020; right 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.
 
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Brand Name
UNK ATTUNE KNEE PATELLA
Type of Device
ATTUNE PATELLA
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key10959664
MDR Text Key219977764
Report Number1818910-2020-26341
Device Sequence Number1
Product Code JWH
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 11/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2020
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 Received12/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ATTUNE INSERT 6 X 8MM PS/RP; ATTUNE PS FEMUR SZ6; ATTUNE RP TIBIA SZ5; DOME PATELLA; ATTUNE INSERT 6 X 8MM PS/RP; ATTUNE PS FEMUR SZ6; ATTUNE RP TIBIA SZ5; DOME PATELLA
Patient Outcome(s) Required Intervention;
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