MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE PS RP INSRT SZ5 5MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number 1516-50-505

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 12/04/2018

Event Type  Injury  

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 Description

The patient was revised to address painful knee.

Manufacturer Narrative

(b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, will be filed as appropriate.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H6 patient code: no code available (3191) used to capture the device revision or replacement.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Primary operative notes indicate the patient received a left primary attune to treat osteoarthritis.The patella was resurfaced and competitor cement x 1 was utilized.The procedure was completed without complications.Revision operative notes indicate the patient received a total left knee revision to treat pain secondary to loosening of the tibial tray.Upon entering the joint, the tibial tray was loosened and debonded at the cement to implant interface.The femoral component and patella were well-fixed and retained.There was no reported product problem with the explanted tibial insert.The patient received a depuy revision knee system utilizing depuy cement x 1.The procedure was completed without complications.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary (b)(6) 2021: the investigation was re-opened upon receipt of additional information.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.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.Corrected: g1.

• Brand Name: ATTUNE PS RP INSRT SZ5 5MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8207903
• MDR Text Key: 131772296
• Report Number: 1818910-2019-79484
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295052425
• UDI-Public: 10603295052425
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/04/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 1516-50-505
• Device Catalogue Number: 151650505
• Device Lot Number: 8646302
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 01/02/2019
• Supplement Dates Manufacturer Received: 01/02/2019; 05/28/2020; 02/03/2021
• Supplement Dates FDA Received: 01/04/2019; 06/09/2020; 02/04/2021
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FEM LT SZ 5 CEM; ATTUNE RP TIB BASE SZ 4 CEM; SMARTSET MV 40G - EO
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR