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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 18MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT
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DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 8 18MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT Back to Search Results
Model Number 1516-40-818
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Pain (1994); Joint Laxity (4526)
Date of Event 07/21/2021
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 instability and pain.Doi: (b)(6) 2017, dor: (b)(6) 2021, right knee.
 
Additional 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.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
 
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Brand Name
ATTUNE PS FB INSRT SZ 8 18MM
Common Device Name
ATTUNE IMPLANT : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key12308047
Report Number1818910-2021-17600
Device Sequence Number20045492
Product Code OIY
UDI-Device Identifier10603295050421
UDI-Public10603295050421
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K111433
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
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) 07/21/2021
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 Number1516-40-818
Device Catalogue Number151640818
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 07/21/2021
Supplement Date Received by Manufacturer08/24/2021
Initial Report FDA Received Date08/11/2021
Supplement Report FDA Received Date08/26/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
ATTUNE CEMENTED STEM 14X50MM; ATTUNE PS FB INSRT SZ 8 18MM; ATTUNE PS FEM RT SZ 8 CEM; ATUNE CRS FB TIB BASE SZ 8 CEM; ATTUNE CEMENTED STEM 14X50MM; ATTUNE PS FB INSRT SZ 8 18MM; ATTUNE PS FEM RT SZ 8 CEM; ATUNE CRS FB TIB BASE SZ 8 CEM
Outcome Attributed to Adverse Event Required Intervention;
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