Vanguard® SSK 360 Knee System 185270Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304481985), received between Oct 10, 2019 and Oct 28, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (2 reports).

5 other recalls cover devices cleared under the same FDA submission (K093293); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT WHEN THE SURGEON OPENED THE IMPLANT, THE STERILE PACKAGING WAS DAMAGED AND STERILITY OF THE DEVICE WAS COMPROMISED. A NEW DEVICE WAS OPENED, HOWEVER, THIS RESULTED IN A SURGICAL DELAY OF 35-40 MINUTES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Information

  MAUDE report 9246136 ↗
• MalfunctionOct 10, 2019Incomplete or Missing Packaging; Tear, Rip or Hole in Device Packaging; Incomplete or Missing Packaging; Tear, Rip or Hole in Device Packaging

  NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9174460 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093293. One submission often covers many models, so check the product and lot details in each record.

• Z-0723-2021 · Dec 1, 2020 · Terminated
  Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty Item Number: 185422
• Z-3249-2018 · Aug 2, 2018 · Terminated
  Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 Intended for use in Total Knee Arthroplasty
• Z-3250-2018 · Aug 2, 2018 · Terminated
  Vanguard 360 Revision Knee System 75x 5mm Universal Tibial Block Augment, Model Number 185224 Intended for use in Total Knee Arthroplasty
• Z-0003-2017 · Aug 8, 2016 · Terminated
  Vanguard 360 Revision Knee System Knee prostheses
• Z-2242-2014 · Jul 1, 2014 · Terminated
  Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRUMENT FEMORAL BOSS REAMER NON-STERILE, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE P.O. BOX 587 WARSAW, IN 4658