• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » Revision rates prompt recalls for Johnson & Johnson’s DePuy Synthes, Zimmer Biomet

Revision rates prompt recalls for Johnson & Johnson’s DePuy Synthes, Zimmer Biomet

January 17, 2018 By Brad Perriello

recallsHigh revision rates for orthopedic implants prompted recalls in recent months for Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Synthes and Zimmer Biomet (NYSE:ZBH).

Last month DePuy Synthes recalled a stand-alone element of its Sigma HP partial knee replacement, the Sigma HP PFJ cemented trochlear implant, “based on elevated revision rates observed as part of the company’s post-market surveillance process.” No other Sigma HP implant or total knee is implicated in the recall, J&J said.

“Further distribution or use of the affected implants is to cease immediately, and the product is now discontinued. The company recommends that surgeons use alternative implants or consider a total knee replacement,” the company said in a field safety notice dated December 2017. “The possible clinical implications related to the affected Sigma HP PFJ cemented trochlear implants include poor joint mechanics (malalignment, instability, and/or dislocation/subluxation). The clinical implications above may potentially require revision surgery.”

J&J said it’s distributed roughly 7,500 of the devices worldwide since 2006.

Zimmer Biomet’s recall involves a product formerly distributed by DePuy, the Ace trochanteric nail system for treating femoral fractures, sent out between July 2012 and December 2017. In a Jan. 15 field safety notice, the Warsaw, Ind.-based orthopedics giant said the device “failed clinical analysis for survivorship pursuant to the acceptance criteria for the [device performance review] protocol for the ATN system.”

The issue could lead to “secondary reduction loss or lateral sliding of the screw resulting in a revision surgery” and “screw cut-out resulting in a total hip arthroplasty or revision surgery,” the company said.

Filed Under: Orthopedics, Recalls, Regulatory/Compliance Tagged With: depuysynthes, Johnson and Johnson, Zimmer Biomet

More recent news

  • Vicarious Surgical inks surgical robot collab with hospital, eyes first clinical patients
  • Bioliberty launches hub for soft-robotic wearable devices
  • Zynex submits laser pulse oximeter to FDA
  • Roche invests $550M to make Indianapolis a CGM manufacturing hub
  • Product liability lawsuits target Medtronic, Boston Scientific spinal cord stim tech

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy