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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 7 10MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT
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DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 7 10MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT Back to Search Results
Model Number 1516-40-710
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Osteolysis (2377)
Date of Event 03/02/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Initial reporter occupation: lawyer.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
Medical records ad 25 nov 2020 were reviewed.On (b)(6) 2016, the patient had a left total knee arthroplasty to address left knee osteoarthritis.Depuy components including depuy patella were implanted with competitor cement x2.There were no complications reported.On (b)(6) 2020, the patient had a revision left total arthroplasty with revision of femoral and tibial components to address failed left total knee arthroplasty with loose tibial component.During the procedure the surgeon observed osteolysis around the femoral components.The femoral component was not grossly loose, but was removed.There was bone loss about the medial aspect of the tibial component.There was no loosening interface provided for the loose tibial tray.The patella was noted to be well-fixed and tracking well.The patella was not revised.Depuy components were implanted along with competitor cement during this revision.Doi: (b)(6) 2016 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.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 lot code was provided, a manufacturing records evaluation (mre) was not performed.
 
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Brand Name
ATTUNE PS FB INSRT SZ 7 10MM
Common Device Name
ATTUNE IMPLANT : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key11020058
Report Number1818910-2020-27056
Device Sequence Number17129690
Product Code JWH
UDI-Device Identifier10603295050247
UDI-Public10603295050247
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K111433
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 12/07/2020
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 Expiration Date03/31/2019
Device Model Number1516-40-710
Device Catalogue Number151640710
Device Lot Number509211
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 12/07/2020
Supplement Date Received by Manufacturer01/19/2021
Initial Report FDA Received Date12/16/2020
Supplement Report FDA Received Date01/19/2021
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 FB TIB BASE SZ 7 CEM; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FB INSRT SZ 7 10MM; ATTUNE PS FEM LT SZ 7 CEM; STRYKER SIMPLEX BONE CEMENT; STRYKER SIMPLEX BONE CEMENT; ATTUNE FB TIB BASE SZ 7 CEM; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FB INSRT SZ 7 10MM; ATTUNE PS FEM LT SZ 7 CEM; STRYKER SIMPLEX BONE CEMENT; STRYKER SIMPLEX BONE CEMENT
Outcome Attributed to Adverse Event Required Intervention;
Patient Age59 YR
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