MAUDE Adverse Event Report: DEPUY IRELAND 961610 ATTUNE MEDIAL ANAT PAT 41MM; ATTUNE IMPLANT : KNEE PATELLA

Catalog Number 151810041

Device Problems Loss of or Failure to Bond (1068); Migration or Expulsion of Device (1395)

Patient Problems Unspecified Infection (1930); Not Applicable (3189)

Event Date 05/22/2018

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.

Event Description

Patient was revised to address infection and loosening of the tibia and patella component at cement to implant interface.Cement manufacturer is from depuy.It was also reported that patient's bmi is above 50 and tibia has begun to collapse into varus.All implants were removed and static cement spacer was placed.The femur was not loose.Doi: (b)(6) 2015; dor: (b)(6) 2018; left knee.

Manufacturer Narrative

Was reported for migration in error.Should be reported for loss of or failure to bond.

Manufacturer Narrative

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

• Brand Name: ATTUNE MEDIAL ANAT PAT 41MM
• Type of Device: ATTUNE IMPLANT : KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND 961610; loughbeg ringaskiddy; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 961610 ; loughbeg ringaskiddy; cokr ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7605528
• MDR Text Key: 111184842
• Report Number: 1818910-2018-62333
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295056652
• UDI-Public: 10603295056652
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 151810041
• Device Lot Number: 3465336
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2018
• Date Device Manufactured: 10/30/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR