MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 9 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Model Number	1506-00-009
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Malposition of Device (2616); Unintended Movement (3026)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	06/06/2016
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 pain, tibial tray migration, malpositioning and loosening at the cement to implant interface.Competitor cement manufacturer was used during the primary operation.The patella component was not revised.On (b)(6) 2016, the underwent a right knee total knee arthroplasty with the implantation of depuy attune knee.Doi: (b)(6) 2016; dor: (b)(6) 2016 right knee.
Additional Manufacturer Narrative
Product complaint # : (b)(4).This is a duplicate report of 1818910-2016-24218.1818910-2020-03015 is being retracted as it is report duplication.1818910-2016-24218 will be kept for investigation purposes.
Additional Manufacturer Narrative
Product complaint # (b)(4).This is a duplicate report of 1818910-2016-24218.1818910-2020-03015 is being retracted as it is report duplication.1818910-2016-24218 will be kept for investigation purposes.

• Brand Name: ATTUNE FB TIB BASE SZ 9 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9632621
• Report Number: 1818910-2020-03015
• Device Sequence Number: 11396704
• Product Code: JWH
• UDI-Device Identifier: 10603295042433
• UDI-Public: 10603295042433
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2020

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 Expiration Date: 12/31/2023
• Device Model Number: 1506-00-009
• Device Catalogue Number: 150600009
• Device Lot Number: 7829493
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 03/03/2020; 03/31/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 03/12/2020; 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE CR FB INSRT SZ 10 5MM; ATTUNE CR FEM RT SZ 10 CEM; ATTUNE MEDIAL DOME PAT 41MM; COMPETITOR CEMENT; ATTUNE CR FB INSRT SZ 10 5MM; ATTUNE CR FEM RT SZ 10 CEM; ATTUNE MEDIAL DOME PAT 41MM; COMPETITOR CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Weight: 188