MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 3 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Catalog Number 150600003

Device Problem Loss of or Failure to Bond (1068)

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

Event Date 02/26/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medical records received 17 june 2019 and were reviewed 17 september 2019 for mdr reportability.On (b)(6) 2015 the patient underwent total right knee arthroplasty due to rheumatoid arthritis and osteoarthritis of the right knee.It was noted the patella was resurfaced.The surgeon reported no intraoperative complications.The patient was implanted with the attune knee system and unknown bone cement.On (b)(6) 2018, the patient underwent a right knee revision due to loosening, ankylosis, and pain.The surgeon indicated the tibial tray came unbonded at the tray to cement interface.There were no complaints against the femoral component, though it was revised.The surgeon reported the patella was not loose, it was not revised.The patient was implanted with a competitor system and there were no complications to the procedure.Doi: (b)(6) 2015 dor: (b)(6) 2018 (rt knee).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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 : the device associated with this report was not 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 : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE FB TIB BASE SZ 3 CEM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9166094
• MDR Text Key: 161570925
• Report Number: 1818910-2019-108298
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295042372
• UDI-Public: 10603295042372
• Combination Product (y/n): N
• PMA/PMN Number: K101433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 150600003
• Device Lot Number: 7780612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE CR FB INSERT SZ 4 7MM; ATTUNE CR FEM RT SZ 4 CEM; ATTUNE MEDIAL DOME PAT 32MM; ATTUNE CR FB INSERT SZ 4 7 MM; ATTUNE CR FEM RT SZ 4 CEM; ATTUNE MEDIAL DOME PAT 32 MM
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR