MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE CR FEM RT SZ 6 NAR CEM; ATTUNE IMPLANT : KNEE FEMORAL

Catalog Number 150400226

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Fever (1858); Unspecified Infection (1930); Necrosis (1971); Pain (1994); No Code Available (3191)

Event Date 06/15/2017

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.(b)(4).

Event Description

The patient underwent a right total knee arthroplasty utilizing attune system on (b)(6) 2015.She later underwent a two stage revision for pain, fever, and infection noting purulence from aspirated knee requiring iv antibiotics on (b)(6) 2017.Surgeon found the femoral component to be poorly fixed (interface unknown) with necrotic looking bone.He also noted the tibial component to be grossly loose(interface unknown).All components removed.On (b)(6) 2017, the second stage of the revision was completed.Patient underwent a left attune tka on (b)(6) -2014 captured in a linked pc.Doi: (b)(6) 2015; dor: (b)(6) 2017.

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.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 CR FEM RT SZ 6 NAR CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8361359
• MDR Text Key: 136852618
• Report Number: 1818910-2019-85452
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295041290
• UDI-Public: 10603295041290
• Combination Product (y/n): N
• PMA/PMN Number: K101433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 02/12/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 150400226
• Device Lot Number: 611487
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/12/2019
• Initial Date FDA Received: 02/22/2019
• Supplement Dates Manufacturer Received: 03/28/2019
• Supplement Dates FDA Received: 04/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR