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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 10 CEM; ATTUNE IMPLANT : KNEE FEMORAL
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DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 10 CEM; ATTUNE IMPLANT : KNEE FEMORAL Back to Search Results
Model Number 1504-10-110
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Adhesion(s) (1695); Hemorrhage/Blood Loss/Bleeding (1888); No Code Available (3191)
Date of Event 05/29/2018
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
Medical records were reviewed on ad 26 may 2020 by a clinician to identify patient harms/product issues.Patient received a left primary attune to treat severe degenerative osteoarthritis.The patella was resurfaced and competitor cement x 2 was utilized.The procedure was completed without complications.Patient received a left revision of the insert, femoral component, and tibial tray to treat unspecified mechanical loosening.The patella was retained.Revision operative notes were not provided.Doi: (b)(6) 2015; dor: (b)(6) 2018; left knee.
 
Additional 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.
 
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Brand Name
ATTUNE PS FEM LT SZ 10 CEM
Common Device Name
ATTUNE IMPLANT : KNEE FEMORAL
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key10225866
Report Number1818910-2020-14969
Device Sequence Number2565554
Product Code JWH
UDI-Device Identifier10603295041672
UDI-Public10603295041672
Combination Product (Y/N)N
Initial Reporter StateMS
Initial Reporter CountryUS
PMA/510(K) Number
K111433
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2018
Reporter Type Manufacturer
Report Source consumer,other
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 06/19/2020
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 Expiration Date12/31/2023
Device Model Number1504-10-110
Device Catalogue Number150410110
Device Lot Number477830
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/19/2020
Supplement Date Received by Manufacturer07/09/2020
Initial Report FDA Received Date07/02/2020
Supplement Report FDA Received Date07/10/2020
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 MEDIAL DOME PAT 41MM; ATTUNE PS FEM LT SZ 10 CEM; ATTUNE PS RP INSRT SZ10 5MM; ATTUNE RP TIB BASE SZ 8 CEM; COMPETITOR BONE CEMENT; COMPETITOR BONE CEMENT; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FEM LT SZ 10 CEM; ATTUNE PS RP INSRT SZ10 5MM; ATTUNE RP TIB BASE SZ 8 CEM; COMPETITOR BONE CEMENT; COMPETITOR BONE CEMENT
Outcome Attributed to Adverse Event Required Intervention;
Patient Age70 YR
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