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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 Code Joint Laxity (4526)
Date of Event 03/04/2021
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
Knee revision.Attune primary revised for mid flexion instability.Implants were absolutely solid and no problem regarding the implants at all.
 
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.Device history lot: he 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 product and 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 Key11561504
Report Number1818910-2021-05930
Device Sequence Number4183128
Product Code JWH
UDI-Device Identifier10603295041290
UDI-Public10603295041290
Combination Product (Y/N)N
Initial Reporter CountryNZ
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source consumer,foreign,health profe
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 03/03/2021
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 Number1504-00-226
Device Catalogue Number150400226
Device Lot NumberHY0346
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/04/2021
Supplement Date Received by Manufacturer06/01/2021
Initial Report FDA Received Date03/24/2021
Supplement Report FDA Received Date06/01/2021
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 CR FEM RT SZ 6 NAR CEM; ATTUNE CR RP INSRT SZ 6 6MM; ATTUNE RP TIB BASE SZ 5 CEM; SIMPLEX CEMENT; ATTUNE CR FEM RT SZ 6 NAR CEM; ATTUNE CR RP INSRT SZ 6 6MM; ATTUNE RP TIB BASE SZ 5 CEM; SIMPLEX CEMENT
Outcome Attributed to Adverse Event Required Intervention;
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