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 Insufficient Information (4580)

Event Date 07/27/2021

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 surgeon was unable to seat cementless attune femur.Upon introducing the femoral implant with the introducer, surgeon was unable to seat the femur within 8-10mm from final seating position.There was a surgical delay of 5-10 minutes.

Event Description

Additional information received indicated that surgery time was extended by approximately 5-10 minutes.The cementless femur was removed with the introducer and a cemented femur was opened immediately.Cement was already mixed for the patellar component and the excess available on the field was utilized to apply to the femoral component resulting in minimal extension to the total surgery time.

Manufacturer Narrative

Product complaint # : (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint #(b)(4).Investigation summary : examination of the returned device could not confirm the reported event, and no defect was found.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 : product code 150411106, work order (b)(4), was manufactured on 24-mar-2021.9 parts were manufactured per specification and all raw materials met specification corrected: h3.

• 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: 12341591
• MDR Text Key: 267238418
• Report Number: 1818910-2021-18163
• 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,Followup
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• 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
• Device Lot Number: 9738029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Date Manufacturer Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1