MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ 4 10MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-50-410
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	01/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).(b)(6).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 right primary attune tka to treat degenerative joint disease.The patella was resurfaced and competitor cement was utilized.The procedure was completed without complications.Patient received right knee revision due to pain and flexion instability secondary to loosening and subsidence of the tibial tray.Upon entering the joint, the surgeon confirmed that the tibial tray was loosened and debonded at the cement to implant interface.The femoral component was well-fixed but revised.The patella was well fixed and retained.There was no reported product problem with the explanted tibial insert.The patient received competitor revision components utilizing competitor cement.The procedure was completed without complications.Doi: (b)(6) 2016.Dor: (b)(6) 20190.Right knee.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ATTUNE PS RP INSRT SZ 4 10MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10039500
• Report Number: 1818910-2020-11901
• Device Sequence Number: 16912142
• Product Code: NJL
• UDI-Device Identifier: 10603295052326
• UDI-Public: 10603295052326
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2020

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 Date: 01/31/2018
• Device Model Number: 1516-50-410
• Device Catalogue Number: 151650410
• Device Lot Number: 3563933
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/28/2020
• Supplement Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 05/08/2020
• Supplement Report FDA Received Date: 06/10/2020
• 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 MEDIAL DOME PAT 38MM; ATTUNE PS FEM RT SZ 4 CEM; ATTUNE PS RP INSRT SZ 4 10MM; ATTUNE RP TIB BASE SZ 4 CEM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE PS FEM RT SZ 4 CEM; ATTUNE PS RP INSRT SZ 4 10MM; ATTUNE RP TIB BASE SZ 4 CEM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR