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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 8 10MM; TIBIAL INSERT
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DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 8 10MM; TIBIAL INSERT Back to Search Results
Catalog Number 151640810
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 11/13/2017
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
The patient was revised to address infection.Doi: (b)(6) 2017 ; dor: (b)(6) 2017; right knee.
 
Additional Manufacturer Narrative
(b)(4).No device associated with this report was received for examination.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
ATTUNE PS FB INSRT SZ 8 10MM
Common Device Name
TIBIAL INSERT
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key7103906
Report Number1818910-2017-51150
Device Sequence Number16433148
Product Code JWH
UDI-Device Identifier10603295050384
UDI-Public10603295050384
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
PMA/510(K) Number
K111433
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date (Section B) 11/13/2017
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 Number151640810
Device Lot NumberHA5498
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/13/2017
Supplement Date Received by Manufacturer03/21/2018
Initial Report FDA Received Date12/11/2017
Supplement Report FDA Received Date03/21/2018
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 Age57 YR
Patient Weight113
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