MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR RP INSRT SZ 7 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-30-706
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Synovitis (2094); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Initial reporter occupation: lawyer.Dmf# - 13704.Trade name - gentamicin sulphate.Active ingredient(s) - gentamicin sulphate.Dosage form - powder.Strength - 1.0g active in our cements.(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 received a left primary attune tka to treat post-traumatic osteoarthritis.The patella was resurfaced and depuy cement was utilized.The procedure was completed without complications.Patient received a left knee revision to treat suspected to loosening.Upon entering the joint, synovitis and bony overgrowth was debrided, and tight flexion identified.The femoral component was loose at the cement to bone interface and revised.The tibial tray was loosened and debonded at the cement to implant interface and revised.There was no reported product problem with the revised tibial insert.Patella was retained.The patient was revised with competitor revision components utilizing competitor cement.The procedure was completed without complications.Doi: (b)(6) 2014, dor: (b)(6) 2019, left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary (b)(6) 2021.No device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.H10 additional narrative: added: d10.

• Brand Name: ATTUNE CR RP INSRT SZ 7 6MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11659626
• Report Number: 1818910-2021-07841
• Device Sequence Number: 11664234
• Product Code: NJL
• UDI-Device Identifier: 10603295047995
• UDI-Public: 10603295047995
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• 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): 03/31/2021

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 Number: 1516-30-706
• Device Catalogue Number: 151630706
• Device Lot Number: 7787294
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 04/20/2021
• 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 FEM LT SZ 7 CEM; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE RP TIB BASE SZ 8 CEM; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR