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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
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 cemented implant removed.Components were explanted and inserted abx loaded spacer.Doi: (b)(6) 2020.Dor: (b)(6) 2020; left knee.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.
 
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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 Key10137916
Report Number1818910-2020-13570
Device Sequence Number17011254
Product Code NJL
UDI-Device Identifier10603295041924
UDI-Public10603295041924
Combination Product (Y/N)N
Initial Reporter StateMO
Initial Reporter CountryUS
PMA/510(K) Number
K140881
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 Other Health Care Professional
Type of Report Initial,Followup
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
Initial Date Received by Manufacturer 06/01/2020
Supplement Date Received by Manufacturer07/21/2020
Initial Report FDA Received Date06/10/2020
Supplement Report FDA Received Date07/21/2020
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; 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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