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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 4 NAR CEM; ATTUNE IMPLANT : KNEE FEMORAL
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DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 4 NAR CEM; ATTUNE IMPLANT : KNEE FEMORAL Back to Search Results
Model Number 1504-10-124
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Hypersensitivity/Allergic reaction (1907); Muscular Rigidity (1968); Pain (1994); No Code Available (3191)
Date of Event 11/11/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(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 underwent a left knee revision due to pain, stiffness, possible allergic reaction to nickel, and tibial tray loosening at the cement to implant interface.The femoral component was well-fixed but revised.The patellar component was retained.Unknown cement was used during the primary operation.Doi: (b)(6) 2017.Dor: (b)(6) 2019; left knee.
 
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.
 
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Brand Name
ATTUNE PS FEM LT SZ 4 NAR CEM
Common Device Name
ATTUNE IMPLANT : KNEE FEMORAL
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key10033489
Report Number1818910-2020-11821
Device Sequence Number16847262
Product Code JWH
UDI-Device Identifier10603295041696
UDI-Public10603295041696
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K111433
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2019
Reporter Type Manufacturer
Report Source consumer,other
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 04/27/2020
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 Model Number1504-10-124
Device Catalogue Number150410124
Device Lot Number8623776
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/27/2020
Supplement Date Received by Manufacturer06/16/2020
Initial Report FDA Received Date05/07/2020
Supplement Report FDA Received Date06/17/2020
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 FB TIB BASE SZ 4 CEM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FB INSRT SZ 4 5MM; COMPETITOR BONE CEMENT; COMPETITOR BONE CEMENT; ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FB INSRT SZ 4 5MM; COMPETITOR BONE CEMENT; COMPETITOR BONE CEMENT
Outcome Attributed to Adverse Event Required Intervention;
Patient Age46 YR
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