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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FEM POR PS LT SZ 7; ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL
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DEPUY IRELAND - 9616671 ATTUNE FEM POR PS LT SZ 7; ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL Back to Search Results
Model Number 1504-11-107
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Codes Unspecified Infection (1930); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event 06/01/2020
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 suspected infection and loosening of the tibial tray and femoral components at the bone to implant interface.Depuy cement was used for the explanted cemented implant.Components were explanted and abx loaded spacer was inserted.Doi: (b)(6) 2020; dor: (b)(6) 2020; left knee.
 
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Brand Name
ATTUNE FEM POR PS LT SZ 7
Common Device Name
ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key10144653
Report Number1818910-2020-13664
Device Sequence Number19629206
Product Code NJL
UDI-Device Identifier10603295041924
UDI-Public10603295041924
Combination Product (Y/N)N
Initial Reporter StateMO
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 06/01/2020
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 Number1504-11-107
Device Catalogue Number150411107
Device Lot Number9047879
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/01/2020
Initial Report FDA Received Date06/11/2020
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 MEDIAL DOME PAT 38MM; ATTUNE PS RP INSRT SZ 7 12MM; ATTUNE RP TIB BASE SZ 8 POR; DEPUY CMW 2 20G
Outcome Attributed to Adverse Event Required Intervention;
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