MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FEM POR PS LT SZ 6; ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL

Model Number 1504-11-106

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/07/2021

Event Type  malfunction  

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.

Event Description

It was reported that the doctor's last 3 attune pressfit femurs have been very difficult to implant/seat.

• Brand Name: ATTUNE FEM POR PS LT SZ 6
• Type of Device: ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12235105
• MDR Text Key: 263822258
• Report Number: 1818910-2021-16186
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 10603295041917
• UDI-Public: 10603295041917
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1504-11-106
• Device Catalogue Number: 150411106
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE FEM POR PS LT SZ 6; UNKNOWN BONE CEMENT; ATTUNE FEM POR PS LT SZ 6; UNKNOWN BONE CEMENT