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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM LT SZ 8 CEM; ATTUNE KNEE FEMORAL
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DEPUY IRELAND - 9616671 ATTUNE CR FEM LT SZ 8 CEM; ATTUNE KNEE FEMORAL Back to Search Results
Model Number 1504-00-108
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 08/02/2021
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
Patient was revised due to infected knee.Removed femur, tibia and insert.Antibiotic spacer put in.Doi: (b)(6) 2021, dor: (b)(6) 2021, left knee.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: 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).A manufacturing records evaluation (mre) was not performed.
 
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Brand Name
ATTUNE CR FEM LT SZ 8 CEM
Common Device Name
ATTUNE KNEE FEMORAL
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key12358841
Report Number1818910-2021-18472
Device Sequence Number3735881
Product Code MBH
UDI-Device Identifier10603295041092
UDI-Public10603295041092
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
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) 08/02/2021
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 Number1504-00-108
Device Catalogue Number150400108
Device Lot NumberJ7619M
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/02/2021
Supplement Date Received by Manufacturer08/26/2021
Initial Report FDA Received Date08/24/2021
Supplement Report FDA Received Date08/30/2021
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 FB INSRT SZ 8 5MM.; ATTUNE CR FEM LT SZ 8 CEM.; ATTUNE FB TIB BASE SZ 8 CEM.; ATTUNE CR FB INSRT SZ 8 5MM; ATTUNE CR FEM LT SZ 8 CEM; ATTUNE FB TIB BASE SZ 8 CEM
Outcome Attributed to Adverse Event Required Intervention;
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