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

Catalog Number UNK ATTUNE FEMORAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/05/2019

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

The article "comparison between the attune and pfc sigma in total knee arthroplasty: no difference in patellar clunk and crepitus or anterior knee pain" written by dexter k.Bateman, md, jared s.Preson, md, mba, steven mennona, md, evan gui, ba, and stephen kayiaros, md published by orthopedics accepted by publisher 5 aug 2019 was reviewed.Doi: 10.3928/01477447-20200812-05.The article's purpose was to compare the incidence of patellar clunk and crepitus or anterior pain in attune tka construct verse pfc sigma tka construct.Patella resurfacing was performed in all patients and cement manufacturer is not identified.Data was compiled from 103 attune knees and 114 sigma knees (80 with fixed bearing and 34 with mobile bearing).Findings were that no significant differences in outcomes between the two product platforms.This complaint captures the associated adverse events reported.Exact quantities of involved implants cannot be accurately determined as patients may experience more than one adverse event.Depuy products: attune femoral, attune patella, attune insert, attune tray, sigma pfc femoral, sigma pfc patella, sigma pfc insert, sigma pfc tray.Adverse events: painful patellofemoral crepitus and clunk (qty 15 total attune - 3 were treated with arthroscopic synovectomy; qty 23 total pfc sigma - 7 were treated arthroscopic synovectomy).Arthrofibrosis (qty 3 attune treated by manipulation under general anesthesia; qty 1 pfc sigma treated by manipulation under general anesthesia).Prosthetic joint infection (qty 1 attune treated by irrigation and debridement; qty 12 pfc sigma treated by irrigation and debridement).

Manufacturer Narrative

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.

Event Description

Additional information received reporting the cement utilized with the prostheses within literature article¿s data was low viscosity simplex (stryker) and no antibiotics were utilized in the cement.

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 FEMORAL
• Type of Device: FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11405424
• MDR Text Key: 234663277
• Report Number: 1818910-2021-04280
• 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: health professional,literatur
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• 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: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention