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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM RT SZ 9 CEM; ATTUNE IMPLANT : KNEE FEMORAL
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DEPUY IRELAND - 9616671 ATTUNE PS FEM RT SZ 9 CEM; ATTUNE IMPLANT : KNEE FEMORAL Back to Search Results
Model Number 1504-10-209
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 06/30/2021
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 right total knee that is infected.The surgeon removed the components and implanted temporary parts.All components were well fixed.Doi: (b)(6) 2019, 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.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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 PS FEM RT SZ 9 CEM
Common Device Name
ATTUNE IMPLANT : KNEE FEMORAL
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key12200689
Report Number1818910-2021-15593
Device Sequence Number11854777
Product Code JWH
UDI-Device Identifier10603295041801
UDI-Public10603295041801
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
PMA/510(K) Number
P830055
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 company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 06/30/2021
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 Number1504-10-209
Device Catalogue Number150410209
Device Lot Number8617465
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/30/2021
Supplement Date Received by Manufacturer08/16/2021
Initial Report FDA Received Date07/20/2021
Supplement Report FDA Received Date08/17/2021
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 MEDIAL DOME PAT 41MM; ATTUNE PS FEM RT SZ 9 CEM; ATTUNE PS RP INSRT SZ 9 10MM; ATTUNE RP TIB BASE SZ 9 CEM; BONE CEMENT (MFG. AND PRODUCT NAME UNKNOWN); ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FEM RT SZ 9 CEM; ATTUNE PS RP INSRT SZ 9 10MM; ATTUNE RP TIB BASE SZ 9 CEM; BONE CEMENT (MFG. AND PRODUCT NAME UNKNOWN)
Outcome Attributed to Adverse Event Required Intervention;
Patient Age64 YR
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