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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUNE CRS FB TIB BASE SZ 8 CEM; ATTUNE STEMMABLE TIBIA IMPLANTS : KNEE TIBIAL TRAY
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DEPUY IRELAND - 9616671 ATUNE CRS FB TIB BASE SZ 8 CEM; ATTUNE STEMMABLE TIBIA IMPLANTS : KNEE TIBIAL TRAY Back to Search Results
Model Number 1506-40-008
Medical Device Problem Code Difficult to Insert (1316)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 10/21/2020
Type of Reportable Event Malfunction
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
It was reported that the patient had a left tka.The surgeon could not get the poly to lock into the tray.A second poly was opened & implanted.A 15 minute surgical delay was reported.Doe: (b)(6) 2020; left knee.
 
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Brand Name
ATUNE CRS FB TIB BASE SZ 8 CEM
Common Device Name
ATTUNE STEMMABLE TIBIA IMPLANTS : KNEE TIBIAL TRAY
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key10792696
Report Number1818910-2020-24024
Device Sequence Number19580319
Product Code JWH
UDI-Device Identifier10603295042822
UDI-Public10603295042822
Combination Product (Y/N)N
Initial Reporter StateKS
Initial Reporter CountryUS
PMA/510(K) Number
K160700
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
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) 10/21/2020
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? Yes
Operator of Device Health Professional
Device Model Number1506-40-008
Device Catalogue Number150640008
Device Lot Number8656511
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/21/2020
Supplement Date Received by Manufacturer12/10/2020
Initial Report FDA Received Date11/05/2020
Supplement Report FDA Received Date12/11/2020
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 FB INSRT SZ 8 7MM.; ATTUNE PS FB INSRT SZ 8 7MM
Outcome Attributed to Adverse Event Required Intervention;
Patient Age73 YR
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