MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK ATTUNE KNEE TIBIAL TRAY

Catalog Number UNK ATTUNE KNEE TIBIAL TRAY

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

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

The literature article titled, "a randomized controlled trial comparing tibial migration of the attune cemented cruciate-retaining knee prosthesis with the pfc-sigma design" written by b.L.Kaptein, p.Den hollander, b.Thomasson, m.Fiocco, and r.G.H.H.Nelissen published by the bone and joint journal 2020 was reviewed.The article's purpose was to compare migration of the cemented attune fixed bearing tibial component with the cemented pfc sigma fixed bearing cr tibial component.Data was compiled from 35 attune cases and 33 pfc sigma cases ultimately after some cases were lost in follow up.Any deaths were noted as unrelated.The article focuses solely on the tibial components of each platform for migration measurements.Results were minimal migration found in both groups with detection of radiolucent lines at cement-implant interface in radiographs but no cases were revised for loosening at the time of 2 year follow up.Article reports two generalized adverse events with pfc sigma group but ones adverse event is not related to tka (release of posterior tibial nerve in tarsal tunnel in 2nd postoperative year).Patella resurfacing not discussed and cement manufacturer is not identified.Depuy products: attune tibial tray and pfc sigma tibial tray, pfc sigma femoral, pfc sigma insert.Adverse event for attune tibial tray: radiographic detection of migration (no treatment provided.) adverse events for pfc sigma group: radiographic detection of migration (no treatment provided.) infection (treated by arthrotomy, debridement, liner exchange and six weeks of antibiotics.).

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 device history record (dhr) review, was not possible because the required lot number was not provided.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.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: UNK ATTUNE KNEE TIBIAL TRAY
• Type of Device: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11177736
• MDR Text Key: 231801065
• Report Number: 1818910-2021-01248
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ATTUNE KNEE TIBIAL TRAY
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1