MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK ATTUNE FEMORAL

Catalog Number UNK ATTUNE FEMORAL

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); No Code Available (3191)

Event Date 06/08/2020

Event Type  Injury  

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

Revision tkr: attune in-situ however patella kept dislocating and the tibia was loose (cemented non s+ tray).Primary was done 12 months ago, (b)(6) 2019.Reason for revision was due to patella dislocating.No delay in the surgery, no ae reported.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.

Event Description

Additional information received stated that the tibial loosening was at the cement to implant interface.Affected side was the left.

• Brand Name: UNK ATTUNE FEMORAL
• Type of Device: UNK ATTUNE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10176508
• MDR Text Key: 195894272
• Report Number: 1818910-2020-14191
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ATTUNE FEMORAL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CEMENTED NON S+ TRAY; COMPETITOR BONE CEMENT; UNK ATTUNE FEMORAL; UNK ATTUNE KNEE PATELLA; UNK ATTUNE KNEE TIBIAL INSERT; CEMENTED NON S+ TRAY; UNK ATTUNE FEMORAL; UNK ATTUNE KNEE PATELLA; UNK ATTUNE KNEE TIBIAL INSERT
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR