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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM RT SZ 6 NAR CEM; ATTUNE IMPLANT : KNEE FEMORAL
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DEPUY IRELAND - 9616671 ATTUNE CR FEM RT SZ 6 NAR CEM; ATTUNE IMPLANT : KNEE FEMORAL Back to Search Results
Model Number 1504-00-226
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Edema (1820); Unspecified Infection (1930); Pain (1994); Injury (2348); No Code Available (3191)
Date of Event 10/28/2020
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
Clinical adverse event received for septic knee: infection - deep.Event is serious and is considered severe.Event is definitely related to device and is possibly related to procedure.Date of implantation: date of event (onset): (b)(6) 2020, (right knee).Treatment: revision surgery.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Device history review : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
 
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Brand Name
ATTUNE CR FEM RT SZ 6 NAR CEM
Common Device Name
ATTUNE IMPLANT : KNEE FEMORAL
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key10872341
Report Number1818910-2020-25066
Device Sequence Number14535292
Product Code NJL
UDI-Device Identifier10603295041290
UDI-Public10603295041290
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional,study
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 11/06/2020
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 Number1504-00-226
Device Catalogue Number150400226
Device Lot NumberJ1049G
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/06/2020
Supplement Date Received by Manufacturer12/16/2020
Initial Report FDA Received Date11/19/2020
Supplement Report FDA Received Date12/16/2020
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 CEMENTED STEM 14X30MM; ATTUNE CR FEM RT SZ 6 NAR CEM; ATTUNE MEDIAL DOME PAT 38MM; ATUNE CRS FB TIB BASE SZ 6 CEM; DEPUY CMW 3 40G; UNK ATTUNE KNEE TIBIAL INSERT; ATTUNE CEMENTED STEM 14X30MM; ATTUNE CR FEM RT SZ 6 NAR CEM; ATTUNE MEDIAL DOME PAT 38MM; ATUNE CRS FB TIB BASE SZ 6 CEM; DEPUY CMW 3 40G; UNK ATTUNE KNEE TIBIAL INSERT
Outcome Attributed to Adverse Event Required Intervention;
Patient Age76 YR
Patient Weight91
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