MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FEM POR CR LT SZ 4; ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL

Model Number 1504-01-104

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Fall (1848)

Event Date 08/12/2021

Event Type  Injury  

Manufacturer Narrative

(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 patient fell after primary knee surgery on (b)(6) and split open incision.Surgeon then did a revision i&d, removing implants (femur, tibia, insert), irrigating the wound, and replacing with new cemented implants.Patella implant was retained.No deficiencies were noted with implants.No surgical delay.Doi: (b)(6) 2021, dor: (b)(6) 2021, left knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE FEM POR CR LT SZ 4
• Type of Device: ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12406206
• MDR Text Key: 269299487
• Report Number: 1818910-2021-19056
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 10603295041337
• UDI-Public: 10603295041337
• Combination Product (y/n): N
• 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: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1504-01-104
• Device Catalogue Number: 150401104
• Device Lot Number: 9614655
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE CR RP INSRT SZ4 7MM; ATTUNE FEM POR CR LT SZ 4; ATTUNE RP TIB BASE SZ 5 POR; ATTUNE CR RP INSRT SZ4 7MM; ATTUNE FEM POR CR LT SZ 4; ATTUNE RP TIB BASE SZ 5 POR
• Patient Outcome(s): Required Intervention