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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 6 8MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT
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DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 6 8MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT Back to Search Results
Model Number 1516-20-608
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Pain (1994); No Code Available (3191)
Date of Event 05/29/2020
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.Tibial lights up in bone scan.Upon removal, the tibia did not seem grossly loose.X-rays did not have obvious signs of loosening either.The surgeon took out the 2 tibia parts and left the femur and patella.The surgeon implanted a attune revision size 4 tray, 37 sleeve and a 14x110 stem.A competitor cement was used.Doi: (b)(6) 2014, dor: (b)(6) 2020, right knee.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthese 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 CR FB INSRT SZ 6 8MM
Common Device Name
ATTUNE IMPLANT : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key10138452
Report Number1818910-2020-13601
Device Sequence Number19273095
Product Code JWH
UDI-Device Identifier10603295045793
UDI-Public10603295045793
Combination Product (Y/N)N
Initial Reporter StateNE
Initial Reporter CountryUS
PMA/510(K) Number
K101433
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
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) 05/29/2020
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 Number1516-20-608
Device Catalogue Number151620608
Device Lot Number7785983
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 05/29/2020
Supplement Date Received by Manufacturer07/14/2020
Initial Report FDA Received Date06/10/2020
Supplement Report FDA Received Date07/15/2020
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 CR FB INSRT SZ 6 8MM; ATTUNE FB TIB BASE SZ 5 CEM; COMPETITOR BONE CEMENT; UNKNOWN ATTUNE KNEE FEMORAL; UNKNOWN ATTUNE KNEE PATELLA; ATTUNE CR FB INSRT SZ 6 8MM; ATTUNE FB TIB BASE SZ 5 CEM; COMPETITOR BONE CEMENT; UNKNOWN ATTUNE KNEE FEMORAL; UNKNOWN ATTUNE KNEE PATELLA
Outcome Attributed to Adverse Event Required Intervention;
Patient Age75 YR
Patient Weight97
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