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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 3 CEM; ATTUNE IMPLANT : KNEE FEMORAL
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DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 3 CEM; ATTUNE IMPLANT : KNEE FEMORAL Back to Search Results
Model Number 1504-10-103
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Pain (1994)
Date of Event 03/19/2021
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
Compass case (b)(4) report: the patient was revised due to pain.The physician revised femur components to crs with stem.Doi: (b)(6) 2017, 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 PS FEM LT SZ 3 CEM
Common Device Name
ATTUNE IMPLANT : KNEE FEMORAL
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key12487182
Report Number1818910-2021-20360
Device Sequence Number3350368
Product Code JWH
UDI-Device Identifier10603295041603
UDI-Public10603295041603
Combination Product (Y/N)N
Initial Reporter StateKS
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
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) 03/19/2021
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 Number1504-10-103
Device Catalogue Number150410103
Device Lot Number8444164
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/19/2021
Supplement Date Received by Manufacturer09/27/2021
Initial Report FDA Received Date09/17/2021
Supplement Report FDA Received Date09/29/2021
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 32MM; ATTUNE POS FEM AUG SZ 3 8MM; ATTUNE PS FB INSRT SZ 3 6MM; ATTUNE PS FEM LT SZ 3 CEM; COMPETITOR BONE CEMENT; ATTUNE MEDIAL DOME PAT 32MM; ATTUNE POS FEM AUG SZ 3 8MM; ATTUNE PS FB INSRT SZ 3 6MM; ATTUNE PS FEM LT SZ 3 CEM; COMPETITOR BONE CEMENT
Outcome Attributed to Adverse Event Required Intervention;
Patient Age63 YR
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