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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ 5 12MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT
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DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ 5 12MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT Back to Search Results
Model Number 1516-50-512
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 05/06/2021
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
Patient was revised due to infection.I&d and poly exchange was done.Doi: (b)(6) 2021.Dor: (b)(6) 2021 left knee.
 
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Brand Name
ATTUNE PS RP INSRT SZ 5 12MM
Common Device Name
ATTUNE IMPLANT : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key11851750
Report Number1818910-2021-10738
Device Sequence Number14401062
Product Code NJL
UDI-Device Identifier10603295052470
UDI-Public10603295052470
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 05/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model Number1516-50-512
Device Catalogue Number151650512
Device Lot Number9379463
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 05/06/2021
Supplement Date Received by Manufacturer06/30/2021
Initial Report FDA Received Date05/19/2021
Supplement Report FDA Received Date07/02/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age59 YR
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