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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 Osteolysis (2377); No Code Available (3191)
Event Date 06/26/2018
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
Records indicate patient received an attune tka.No allegations provided of patient injury or product failure, nor report of revision.Doi: (b)(6) 2016; dor: unknown (right).
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.No code available is used to capture synovitis.
 
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Brand Name
ATTUNE MEDIAL DOME PAT 35MM
Type of Device
ATTUNE IMPLANT : KNEE PATELLA
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key9416712
MDR Text Key169272213
Report Number1818910-2019-120739
Device Sequence Number1
Product Code JWH
UDI-Device Identifier10603295056683
UDI-Public10603295056683
Combination Product (y/n)N
PMA/PMN Number
K103756
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 11/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number1518-20-035
Device Catalogue Number151820035
Device Lot Number8201247
Was Device Available for Evaluation? No
Date Manufacturer Received08/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ATTUNE PS FEM RT SZ 5 CEM; ATTUNE PS FEM RT SZ 5 CEM
Patient Outcome(s) Required Intervention;
Patient Age57 YR
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