MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM LT SZ 5 NAR CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number 1504-00-125

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

Patient Problems Adhesion(s) (1695); Pain (1994)

Event Date 05/14/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient received primary bilateral attune tkas to treat osteoarthritis.The patella was resurfaced and an unknown number of depuy cements were used on each knee.The procedure was completed without complications.Patient received a left knee revision to treat pain secondary to loosening of the tibial tray.Upon entering the joint, scar tissue was debrided.The femoral component was well-fixed but 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.The patella was well-fixed and retained.The patient was revised with a competitor revision knee.The procedure was completed without complications.Doi: (b)(6) 2015, dor: (b)(6) 2019, left knee.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes 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.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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE CR FEM LT SZ 5 NAR CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11665391
• MDR Text Key: 245494820
• Report Number: 1818910-2021-07920
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295041146
• UDI-Public: 10603295041146
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 1504-00-125
• Device Catalogue Number: 150400125
• Device Lot Number: 7773990
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2021
• Initial Date FDA Received: 04/14/2021
• Supplement Dates Manufacturer Received: 05/24/2021
• Supplement Dates FDA Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE CR RP INSRT SZ 5 5MM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE RP TIB BASE SZ 4 CEM; SMARTSET HV BONE CEMENT 40G
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR