MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TIB BASE SZ 5 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Catalog Number 150610005

Device Problems Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Injury (2348); No Code Available (3191)

Event Date 07/26/2018

Event Type  Injury  

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Attune claim letter received.Claim letter alleged that patient sustained personal injury as a result of implantation of a defective depuy attune knee device.

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.Patient code: no code available (3191) used to capture the surgical intervention, medical device removal.

Event Description

Medical records received on 17 june 2019 were reviewed to identify patient harms/product issues on 13 november 2019.On (b)(6) 2015, the patient underwent total left knee arthroplasty due to degenerative arthritis.The patella was resurfaced.The surgeon reported no intraoperative complications.The patient was implanted with the attune knee system and smartset bone cement x 2.On (b)(6) 2018, the patient underwent a left knee revision due to loosening of the tibial component, osteolysis, and pain.The surgeon reported the tibial component was easily removed with light tapping, and there was no cement bonded to the tibia, and the tibial cement mantle was completely intact.He noted the femur was revised.The surgeon indicated the patella tracked centrally, was well-fixed, and retained.The patient was implanted with a competitor system and there were no complications to the procedure.Doi: (b)(6) 2015.Dor: (b)(6) 2018 (lt 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.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: ATTUNE RP TIB BASE SZ 5 CEM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork IN ; EI
• MDR Report Key: 8213509
• MDR Text Key: 131961169
• Report Number: 1818910-2019-79802
• Device Sequence Number: 1
• Product Code: NJL
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 150610005
• Device Lot Number: 8108211
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2020
• Patient Sequence Number: 1
• Treatment: ATTUNE PS FEM LT SZ 5 CEM
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR