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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TIB BASE SZ 9 CEM; KNEE TIBIAL TRAY
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DEPUY IRELAND - 9616671 ATTUNE RP TIB BASE SZ 9 CEM; KNEE TIBIAL TRAY Back to Search Results
Model Number 1506-80-009
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Pain (1994)
Date of Event 01/25/2021
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
The patient was revised due to complaining of lateral pain.Doi: (b)(6) 2020.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.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 : 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).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.
 
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Brand Name
ATTUNE RP TIB BASE SZ 9 CEM
Common Device Name
KNEE TIBIAL TRAY
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key11293605
Report Number1818910-2021-02584
Device Sequence Number11633401
Product Code NJL
UDI-Device Identifier10603295492214
UDI-Public10603295492214
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
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) 01/25/2021
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 Number1506-80-009
Device Catalogue Number150680009
Device Lot Number9335624
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 01/25/2021
Supplement Date Received by Manufacturer03/10/2021
Initial Report FDA Received Date02/08/2021
Supplement Report FDA Received Date03/11/2021
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 PS FEM LT SZ 9 CEM; ATTUNE PS RP INSRT SZ 9 7MM; ATTUNE RP TIB BASE SZ 9 CEM; ATTUNE PS FEM LT SZ 9 CEM; ATTUNE PS RP INSRT SZ 9 7MM; ATTUNE RP TIB BASE SZ 9 CEM
Outcome Attributed to Adverse Event Required Intervention;
Patient Age61 YR
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