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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FEM POR CR RT SZ 8; ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL
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DEPUY IRELAND - 9616671 ATTUNE FEM POR CR RT SZ 8; ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL Back to Search Results
Model Number 1504-01-208
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Pain (1994)
Date of Event 04/20/2021
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
The patient was revised to address pain.No loosening reported.Doi: unknown dor: (b)(6) 2021 right 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 FEM POR CR RT SZ 8
Common Device Name
ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key11773631
Report Number1818910-2021-09522
Device Sequence Number4061495
Product Code MBH
UDI-Device Identifier10603295041511
UDI-Public10603295041511
Combination Product (Y/N)N
Initial Reporter StateSC
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
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) 04/20/2021
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 Number1504-01-208
Device Catalogue Number150401208
Device Lot Number9243880
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/20/2021
Supplement Date Received by Manufacturer06/08/2021
Initial Report FDA Received Date05/04/2021
Supplement Report FDA Received Date06/09/2021
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 RP INSRT SZ 8 5MM; ATTUNE FEM POR CR RT SZ 8; ATTUNE RP TIB BASE SZ 8 POR; BONE CEMENT (UNK MANUFACTURER & PRODUCT INFO)
Outcome Attributed to Adverse Event Required Intervention;
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