Events

Recall of Device Recall PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by DePuy Orthopaedics, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    67159
  • Event Risk Class
    Class 2
  • Event Number
    Z-1077-2014
  • Event Initiated Date
    2013-12-09
  • Event Date Posted
    2014-02-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124799
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Reason
    Knee implant femoral devices were found to have anomalous microstructure. porosity and the presence of blocky carbides, within the cobalt chrome part, can decrease the overall fatigue strength. this decrease in strength could cause implants to fracture under what would normally be acceptable loads.
  • Action
    The recall is extended to the DePuy Distributor, Hospital, and Surgeon levels. The two affected distributors were contacted by telephone. Written communication to the two hospitals and one surgeon who received the devices will be delivered by DePuy Orthopaedics, Inc. via email or regular mail. The one affected surgeon will also be contacted by telephone by the Medical Safety Officer and a metallurgist, who will discuss the surgeon communication with the surgeon. The sales representatives aid customers in the affected device returns, as needed. The devices will be returned through the normal DePuy Returns process, to attention of Returns and marking H13-30C on the outside of the box. All (21) remaining devices have been verified as being returned and in quarantine. Effectiveness will be determined by product reconciliation, receipt of all hospital reconciliation forms, and receipt of international declaration from the International Affiliate. DePuy will follow-up with the affected hospitals until all hospital reconciliation forms are returned, and DePuy will follow-up with the International Affiliate until all international actions are complete and the international declaration is completed and return.

Device

Device Recall PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices
  • Model / Serial
    Catalog Number 960015 Lot Numbers 7810268 and 7806929 (US) Lot Number 7806934 (OUS)
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-USA including the states of IA, CA, KY, and FL, and the countries of Finland, Germany, Sweden, and Czech Republic.
  • Product Description
    PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) || Used during primary total knee arthroplasty to improve patient mobility.
  • Manufacturer
    DePuy Orthopaedics, Inc.

Manufacturer

DePuy Orthopaedics, Inc.
  • Manufacturer Address
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA