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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE CRS RP INSRT SZ 6 20MM; KNEE TIBIAL INSERT
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DEPUY IRELAND 9616671 ATTUNE CRS RP INSRT SZ 6 20MM; KNEE TIBIAL INSERT Back to Search Results
Catalog Number 151710620
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Unspecified Infection (1930); No Code Available (3191)
Date of Event 12/06/2018
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
Patient was revised to address infection.
 
Additional Manufacturer Narrative
(b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
ATTUNE CRS RP INSRT SZ 6 20MM
Common Device Name
KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI 
MDR Report Key8212836
Report Number1818910-2019-79771
Device Sequence Number2015596
Product Code NJL
UDI-Device Identifier10603295056089
UDI-Public10603295056089
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 12/06/2018
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 Catalogue Number151710620
Device Lot Number8683717
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 12/06/2018
Supplement Date Received by Manufacturer01/18/2019
Initial Report FDA Received Date01/03/2019
Supplement Report FDA Received Date01/22/2019
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age59 YR
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