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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 Codes Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event 09/22/2020
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, mid-flexion instability and tightness in flexion.Pathology confirmed that there was no infection.All components were removed and replaced with attune revision crs with sleeves and stems.After removal of components, the surgeon confirmed that nothing was loose.Doi: (b)(6) 2018, dor: (b)(6) 2020, right knee.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).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.
 
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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 Key10621826
Report Number1818910-2020-21507
Device Sequence Number13747837
Product Code NJL
UDI-Device Identifier10603295492214
UDI-Public10603295492214
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 09/22/2020
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? No
Operator of Device Health Professional
Device Model Number1506-80-009
Device Catalogue Number150680009
Device Lot Number8821719
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 09/22/2020
Supplement Date Received by Manufacturer11/09/2020
Initial Report FDA Received Date10/02/2020
Supplement Report FDA Received Date11/10/2020
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 MEDIAL DOME PAT 41MM; ATTUNE PS FEM RT SZ 9 CEM; ATTUNE PS RP INSRT SZ9 5MM; ATTUNE RP TIB BASE SZ 9 CEM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FEM RT SZ 9 CEM; ATTUNE PS RP INSRT SZ9 5MM; ATTUNE RP TIB BASE SZ 9 CEM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
Outcome Attributed to Adverse Event Required Intervention;
Patient Age56 YR
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